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U.S. Food and Drug Administration Recalls
The Food and Drug Administration (FDA) is responsible for overseeing the safety of all personal care products. While the Federal Food, Drug, and Cosmetic Act, does not generally authorize FDA to "order" a manufacturer to recall a cosmetic product,the agency may request a product recall if the firm is not willing to remove dangerous products from the market without FDA's written request. A recall is a firm's removal or correction of a marketed product that FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action. Recall notices for personal care products may also be found at https://www.fda.gov/safety/recalls/default.htm
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January 30, 2023; Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene
- January 30, 2023
Edgewell Personal Care Company found that some samples of the product contained trace levels of benzene. While benzene is not an ingredient in any Banana Boat products, the review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can. Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. To date, Edgewell has not received any adverse events related to this recall. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources. Daily exposure to benzene in the recalled products would not be expected to cause adverse health consequences according to an independent health assessment using established exposure modeling guidelines.
The voluntarily recalled sunscreen spray products are packaged in aerosol cans. The products were distributed nationwide in the United States through various retailers and online. Edgewell has notified its retailers to remove any remaining recalled product from shelves. Banana Boat will also offer reimbursement for consumers who have purchased a product marked with one of the lot codes in the table above. Lot codes are located on the bottom of the can. Consumers should stop using the affected product immediately and appropriately discard.
Consumers with questions regarding this recall may contact Edgewell Personal Care at 1-888-686-3988 Monday through Friday, 9:00 a.m. to 6:00 p.m. Eastern Time. Consumers may also visit www.bananaboat.comUPC DESCRIPTION
0-79656-04041-8 Banana Boat Hair & Scalp Spray SPF 30 20016AF December 2022 6 oz
0-79656-04041-8 Banana Boat Hair & Scalp Spray SPF 30 20084BF February 2023 6 oz
0-79656-04041-8 Banana Boat Hair & Scalp Spray SPF 30 21139AF April 2024 6 oz
0-79656-04041-8 Banana Boat Hair & Scalp Spray SPF 30 20301CF September 2023 6 oz
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July 29, 2022; Best Brand Consumers Products, Inc. Issues Voluntary Recall of Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% Due to Presence of Methanol and the Mandalorian Hand Sanitizer Ethyl Alcohol 68% Due to the Presence of Benzene.
- July 29, 2022
Best Brands Consumer Products, Inc. is voluntarily recalling two (2) finished product lots of The Mandalorian Hand Sanitizer Ethyl Alcohol 68%, available in green and blue formulations and Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% blue formulation to the consumer level. FDA testing found the presence of benzene in The Mandalorian Hand Sanitizer product and methanol in the Mickey Mouse Hand Sanitizer product. Best Brands imported these two lots, which were produced by a third-party manufacturer. Benzene is classified as a human carcinogen. Substantial exposure to benzene can occur through inhalation, oral, and skin and it may result in cancers including leukemia and blood cancer of the bone marrow and blood disorders, which can be life-threatening.
Mickey Mouse Hand Sanitizer, Ethyl Alcohol 68%, blue color
The Mandalorian Hand Sanitizer, Ethyl Alcohol 68%, blue/green colorConsumers Contact: Best Brands: Quality@BestBrandsintl.com
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March 30, 2022; Unilever Issues Voluntary Nationwide Recall of Suave 24-Hour Protection Aerosol Antiperspirant Powder and Suave 24-Hour Protection Aerosol Antiperspirant Fresh Due to Presence of Slightly Elevated Levels of Benzene.
- March 30, 2022
Unilever United States is voluntarily recalling two Suave 24-Hour Protection Aerosol Antiperspirants to the consumer level. An internal review showed slightly elevated levels of benzene in some product samples. While benzene is not an ingredient in any of the recalled products, the review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can.Unilever is recalling all lots of the products below with an expiration date through September 2023. No other Unilever or Suave products are in the scope of this recall.
Suave 24-Hour Protection Aerosol Antiperspirant Powder
Suave 24-Hour Protection Aerosol Antiperspirant, FreshConsumers with questions regarding this recall can contact Unilever by calling (866) 204-9756, Monday through Friday, 8:30 a.m. to 9 p.m. EST. Visit www.suaverecall.comExternal Link Disclaimer for more information about the impacted products and to learn how to receive reimbursement for eligible products. Consumers should contact their physician or healthcare provider if they have any questions or have experienced any problems that may be related to using these aerosol antiperspirant products.
Company Contact Information: (866) 204-9756
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February 16, 2022; TCP HOT Acquisition LLC dba HRB Brands, Issues Voluntary Nationwide Recall of Sure and Brut Aerosol Sprays Due to the Presence of Benzene.
- February 16, 2022
TCP HOT Acquisition LLC dba HRB Brands is voluntarily recalling all lot numbers with expiration dates on or before August 2023 of the Sure and Brut Aerosol Sprays listed in the table below to the consumer level due to the presence of benzene. While benzene is not an ingredient in any of the recalled products, our review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can. These products were owned and distributed by Helen of Troy Limited prior to June 7, 2021.
Brand Product Description UPC Expiration Date
Brut Classic Antiperspirant Aerosol, 4oz 00827755070085 On or Before August 2023
Brut Classic Antiperspirant Aerosol, 6oz 00827755070108
Brut Classic Deodorant Aerosol, 154g 00827755070177
Brut Classic Deodorant Aerosol, 10oz 00827755070047
Sure Regular Antiperspirant Aerosol, 6oz 00883484002025
Sure Unscented Antiperspirant Aerosol, 6oz 00883484002278Consumers with questions regarding this recall can contact TCP HOT Acquisition LLC by calling 1-866-615-0976 Monday to Friday from 8:30am–5pm (PT). Consumers may also access www.brutsurerecall2022.com
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November 23, 2021; Procter & Gamble Company Issues Voluntary Recall of Specific Old Spice and Secret Aerosol Spray Antiperspirants and Old Spice Below Deck Aerosol Spray Products Due to Detection of Benzene.
- November 23, 2021
The Procter & Gamble Company (NYSE: PG) is voluntarily recalling all lots with expiry through September 2023 of specific Old Spice and Secret aerosol spray antiperspirants and Old Spice Below Deck aerosol spray products sold in the United States, and listed in the table below, to the consumer level due to the presence of benzene detected. The affected products are used as antiperspirants and hygiene products and are packaged in aerosol cans. See table below for Product names and UPC codes and images for further descriptions. We are recalling all lots with expiry through September 2023 of the below products:
UPC Description
012044001912 Old Spice High Endurance AP Spray Pure Sport 12/6oz
012044044759 Old Spice Hardest Working Collection Inv Spray Stronger Swagger 3.8oz
037000729747 Old Spice Hardest Working Collection Inv Spray Pure Sport Plus 12/3.8oz
037000730347 Old Spice Hardest Working Collection Inv Spray Stronger Swagger 12/3.8oz
037000749479 Old Spice Hardest Working Collection Inv Spray Ult Captain 12/3.8oz
037000695714 Old Spice Below Deck Powder Spray Unscented 12/4.9oz
037000695707 Old Spice Below Deck Powder Spray Fresh Air 12/4.9oz
037000586906 Secret Aerosol Powder Fresh Twin Pack
037000711087 Secret Aerosol Powder Fresh 12/6OZ
037000711094 Secret Aerosol Powder Fresh 12/4OZ
037000723721 Secret Fresh Collection Inv Spray Waterlily 3.8oz
037000729860 Secret Fresh Collection Inv Spray Lavender 12/3.8oz
037000729914 Secret Fresh Collection Inv Spray Water Lily 12/3.8oz
037000729921 Secret Fresh Collection Inv Spray Light Essentials 12/3.8oz
037000798842 Secret Fresh Collection Inv Spray Rose 12/3.8oz
037000747642 Secret Outlast Inv Spray Completely Clean 12/3.8oz
037000747727 Secret Outlast Inv Spray Protecting Powder 12/3.8oz
012044048535 Old Spice Pure Sport 2021 Gift SetConsumers with questions regarding this recall can seek more information via the Consumer Care team at 888-339-7689 from Monday – Friday from 9:00am – 6:00pm EST. Consumers can also visit www.oldspice.com or www.secret.com
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November 17, 2021; Odor-Eaters Issues Voluntary Nationwide Recall of Specific Lots of Odor-Eaters Spray Powder and Odor-Eaters Stink Stoppers Spray Due to Benzene Contamination.
- November 17, 2021
Odor-Eaters, owned by Blistex Inc., is voluntarily recalling a total of forty-one lots of two Odor-Eaters spray products to the consumer level due to the presence of benzene. Internal testing identified low levels of benzene contamination in specific lots of these aerosol products. The affected Odor-Eaters® spray products are used as antifungal and foot odor-reducing agents and are packaged in aerosol cans. See table below for UPC, lot number and expiration dates. Refer to the image below for guidance on where to find the lot code details on the can. Forty-one lots of two Odor-Eaters® spray products (Odor-Eaters Spray Powder and Odor-Eaters® Stink Stoppers® Spray) are impacted by this voluntary recall, specifically:
UPC Product Description Lot Expiration Date
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D19K22 10/21
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D19K23 10/21
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D19M24 12/21
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D19M25 12/21
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D19M26 12/21
041388004112
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) ODOR-EATERS SPRAY POWDER (5.3 OZ) D19M27 D19M27 12/21
041388004112 ODOR-EATERS SPRAY POWDER (5.3 OZ) D19M28 12/21
041388004112 ODOR-EATERS SPRAY POWDER (5.3 OZ) D19M29 12/21
041388004112 ODOR-EATERS SPRAY POWDER (5.3 OZ) D19M30 12/21
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D20C01 03/22
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D20C02 03/22
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D20C03 03/22
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D20C04 03/22
041388004112 ODOR-EATERS SPRAY POWDER (5.3 OZ) D20E05 05/22
041388004112 ODOR-EATERS SPRAY POWDER (5.3 OZ) D20E06 05/22
041388004112 ODOR-EATERS SPRAY POWDER (5.3 OZ) D20E07 05/22
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D20F08 06/22
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D20F09 06/22
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D20H10 08/22
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D20H11 08/22
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D20K13 10/22
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D20K14 10/22
041388004112 ODOR-EATERS SPRAY POWDER (5.3 OZ) D20M15 12/22
041388004112 ODOR-EATERS SPRAY POWDER (5.3 OZ) D20M16 12/22
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D21B01 02/23
041388004112 ODOR-EATERS SPRAY POWDER (5.3 OZ) D21B02 02/23
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D21D03 04/23
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D21E04 05/23
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D21F04 05/23
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D21F05 06/23
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D21G01 07/23
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D21G02 07/23
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D21H03 08/23
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D21H04 08/23
041388004112 ODOR-EATERS SPRAY POWDER (4 OZ) D21H05 08/23
041388006499 ODOR-EATERS STINK STOPPERS SPRAY (4 OZ) 041901 No expiry
041388006499 ODOR-EATERS STINK STOPPERS SPRAY (4 OZ) 041902 No expiry
041388006499 ODOR-EATERS STINK STOPPERS SPRAY (4 OZ) 041903 No expiry
041388006499 ODOR-EATERS STINK STOPPERS SPRAY (4 OZ) 041904 No expiry
041388006499 ODOR-EATERS STINK STOPPERS SPRAY (4 OZ) 041905 No expiry
041388006499 ODOR-EATERS STINK STOPPERS SPRAY (4 OZ) 051901 No expiryBeginning on November 18, 2021, at 8am (EST), consumers may access www.odoreatersrecall2021.com
Consumers with questions regarding this recall can contact 1-855-544-4821 with questions.
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September 30, 2021; Coppertone Issues Voluntary Nationwide Recall of Specific Lots of Pure & Simple SPF 50 Spray (2021 Launch), Sport Mineral SPF 50 Spray (2021 Launch), and Travel-Size Coppertone Sport Spray SPF 50 (1.6OZ) Aerosols Sunscreen Sprays Due t
- September 30, 2021
Coppertone, owned by Beiersdorf, is voluntarily recalling specific lots of five Coppertone aerosol sunscreen spray products manufactured between the dates of January 10, 2021 and June 15, 2021 to the consumer level. Coppertone has identified the presence of benzene in these lots of products. Twelve lots of Coppertone spray products are impacted by this voluntary recall, specifically:
UPC Product Description Lot Manufacturing Date
00072140028817 CT P&S BABY SPF50 SPRAY 5OZ 12S TN0083J 1/10/2021
00072140028817 CT P&S BABY SPF50 SPRAY 5OZ 12S TN0083K 1/11/2021
00072140028824 CT P&S KIDS SPF50 SPRAY 5OZ 12S TN00854 1/12/2021
00072140028824 CT P&S KIDS SPF50 SPRAY 5OZ 12S TN00855 1/14/2021
00072140028701 CT SPORT MIN SPF50 SPRAY 5OZ 12S TN008KU 3/15/2021
00072140028701 CT SPORT MIN SPF50 SPRAY 5OZ 12S TN008KV 3/16/2021
00072140028800 CT P&S SPF50 SPRAY 5OZ 12S TN00BR2 3/31/2021
00072140028817 CT P&S BABY SPF50 SPRAY 5OZ 12S TN009GH 3/31/2021
00072140028824 CT P&S KIDS SPF50 SPRAY 5OZ 12S TN00857 4/6/2021
00041100005069 CT SPORT SPRAY SPF50 1.6OZ 24S TN00BU3 5/6/2021
00072140028800 CT P&S SPF50 SPRAY 5OZ 12S TN00CJ4 6/15/2021
00072140028824 CT P&S KIDS SPF50 SPRAY 5OZ 12S TN00CJV 6/15/2021Beginning on September 30, 2021 at 5pm (EST), consumers may contact 1-888-921-1537 with questions Consumers may also access https://www.sunscreenrecall2021.com
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July 14, 2021; Johnson & Johnson Consumer Inc. Issues Voluntary Recall of Specific NEUTROGENA and AVEENO Aerosol Sunscreen Products Due to the Presence of Benzene.
- July 14, 2021
Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five NEUTROGENA and AVEENO aerosol sunscreen product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected products and follow the instructions set forth below. The only sunscreen products impacted are aerosol products, specifically:
NEUTROGENA Beach Defense aerosol sunscreen,
NEUTROGENA Cool Dry Sport aerosol sunscreen,
NEUTROGENA Invisible Daily defense aerosol sunscreen,
NEUTROGENA Ultra Sheer aerosol sunscreen, and
AVEENO Protect + Refresh aerosol sunscreen.Consumers should stop using these specific products and appropriately discard them. Consumers may contact the JJCI Consumer Care Center 24/7 with questions or to request a refund by calling 1-800-458-1673.
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April 28, 2021; Scentsational Soaps & Candles, Inc. Issues Voluntary Nationwide Recall of Scented Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde.
- April 28, 2021
Scentsational Soaps & Candles, Inc., is voluntarily recalling 5 lots of Scentsational Soaps & Candles scented Hand Sanitizers from the Black and White Collection and Photo Real Collection and 3 lots of Ulta Beauty Collection scented Hand Sanitizer Spray packaged in 3.38 and 3.4 fluid ounce spray bottles, respectively, to the consumer level. See products listed in the table below. These products are being recalled after testing conducted by our firm revealed the presence of methanol (wood alcohol), benzene, and acetaldehyde. These products were distributed nationwide in the USA through Ulta Beauty, TJ Maxx, and Marshalls retail stores.
Ulta Beauty Collection Fresh Lemon Scented Hand Sanitizer 100.55ml/3.4 fl. oz. 717897092017
SS Black and White Collection Coconut Breeze Black and White Hand Sanitizer 3.38 FL.OZ. (100mL)
SS Black and White Collection Eucalyptus & Mint Black and White Hand Sanitizer 3.38 FL.OZ. (100mL)
SS Black and White Collection Lavender & Herbs Black and White Hand Sanitizer 3.38 FL.OZ.
SS Black and White Collection Lemon Zest Black and White Hand Sanitizer 3.38 FL.OZ. (100mL)
SS Black and White Collection SS Tangerine & Guava Black and White Hand Sanitizer 3.38 FL.OZ.
SS Photo Real Collection Coconut Breeze Photo Real Hand Sanitizer 3.38 FL.OZ.(100mL)
SS Photo Real Collection Eucalyptus & Mint Photo Real Hand Sanitizer 3.38 FL.OZ.(100mL)
SS Photo Real Collection Lavender & Herbs Photo RealHand Sanitizer 3.38 FL.OZ.(100mL)
SS Photo Real Collection Lemon Zest Photo Real Hand Sanitizer 3.38 FL.OZ.(100mL)
SS Photo Real Collection Tangerine & Guava Photo Real Hand Sanitizer 3.38 FL.OZ.(100mL)Consumers with questions regarding this recall can contact our Customer Support Desk, 1-855-554-8050
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January 16, 2020; Yes To Inc. has issued a voluntary recall of all lots of its Grapefruit Vitamin C Glow-Boosting Unicorn Paper Mask.
- January 16, 2020
Yes To Inc. has issued a voluntary recall of all lots of its Grapefruit Vitamin C Glow-Boosting Unicorn Paper Mask in response to complaints of skin irritation and redness. We have recently seen reports on social media that children have used the Grapefruit Vitamin C Glow-Boosting Unicorn Paper Mask unfortunately in skin irritation. We have also received similar reports from adults who have used the product. As such, we have decided to pull this particular product off of the shelves while we investigate the complaints that we have received and seen online.
The Grapefruit Vitamin C Glow Boosting Unicorn Paper Mask is distributed nationwide in numerous retail and on-line outlets. No other Yes To products are included in this recall.
Yes to Inc. is committed to ensuring the safety and integrity of all of our products and has maintained a strong track record of delivering quality products to our customers since our founding in 2006.
Please return the product to the retailer where purchased, if it has not been used, for a refund. Or, if you have already used the product, contact Yes To at customercare@yesto.com or by phone at 888.929.3786Call: 888.929.3786 on Monday – Friday between 9am – 3pm PST
Company Contact Information
Consumers:
Yes To
888.929.3786
customercare@yesto.com
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October 18, 2019; Johnson & Johnson Consumer Inc. to Voluntarily Recall a Single Lot of Johnson’s Baby Powder in the United States.
- October 18, 2019
Johnson & Johnson Consumer Inc. (JJCI) announced that it is initiating a voluntary recall in the United States of a single lot of its Johnson’s Baby Powder in response to a U.S. Food and Drug Administration (FDA) test indicating the presence of sub-trace levels of chrysotile asbestos contamination (no greater than 0.00002%) in samples from a single bottle purchased from an online retailer. Despite the low levels reported and in full cooperation and collaboration with the FDA, JJCI is initiating this voluntary recall of Lot #22318RB of Johnson’s Baby Powder, from which the tested sample was taken.
In parallel, JJCI has immediately initiated a rigorous, thorough investigation into this matter, and is working with the FDA to determine the integrity of the tested sample, and the validity of the test results. At this early stage of the investigation, JJCI:
Cannot confirm if cross-contamination of the sample caused a false positive.
Cannot confirm whether the sample was taken from a bottle with an intact seal or whether the sample was prepared in a controlled environment.
Cannot confirm whether the tested product is authentic or counterfeit.JJCI has a rigorous testing standard in place to ensure its cosmetic talc is safe and years of testing, including the FDA’s own testing on prior occasions--and as recently as last month--found no asbestos. Thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos. Our talc comes from ore sources confirmed to meet our stringent specifications that exceed industry standards. Not only do we and our suppliers routinely test to ensure our talc does not contain asbestos, our talc has also been tested and confirmed to be asbestos-free by a range of independent laboratories, universities and global health authorities.
If you or someone you provide care for owns a bottle of Johnson’s Baby Powder Lot #22318RB, you are advised to discontinue use of the product. For refund information, contact the Johnson & Johnson Consumer Care Center at www.johnsonsbaby.comExternal Link Disclaimer or by calling +1 (866) 565-2229.
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May 24, 2019; The Village Company Issues Voluntary Nationwide Recall of La Bella Extreme Sport Styling Gel Due to Bacterial Contamination.
- May 24, 2019
The Village Company initiated a voluntary nationwide recall of the 22-ounce La Bella Extreme Sport Styling Gel. Four lots failed micro testing due to bacterial contamination, resulting in potential contamination of 2,377 cases (or 9,508 units). The bacteria found is Burkholderia cepacia and a group of related strains.
Burkholderia cepacia and group of related strains rarely cause infections in healthy people, but pose serious risk to individuals with cystic fibrosis, weakened immune systems, and chronic lung disease. If you are feeling ill after having used the product, consult with your doctor. Washing your hands, hair brush, combs and other hair items, counter tops and other surfaces with warm soapy water are good practices to help prevent the spread of bacteria.The Village Company has not received any reports from consumers related to this recall. Consumers who have a product from any of the affected lots should stop using it immediately. The recalled La Bella Extreme Sport Styling Gel was manufactured by Kapra Cosmetics, Inc. (Kapra) and distributed to retail starting March 5, 2019.
The following lot numbers have been recalled:
La Bella Extreme Sport Styling Gel
Lot Numbers: 19057B, 19072C, 19072E, 19072G
22-ounce bottleThe Village Company was alerted about the potential contamination on May 15, 2019. At that time, The Village Company immediately stopped shipping product, quarantined the remaining amount and is recalling the product from consumers. The Village Company also immediately alerted the 14 affected customers to pull the product from shelves and destroy in the field. These nationwide retailers and wholesale distributors include Kroger (Food 4 Less and Ralphs), Stater Bros, Target, Heb, Cardinal Health, Certco, Cashco Distributors, Bashas, All Essentials, Yosemite Wholesale – Merced, Supervalu, AJ Express and Latin American Distributors, Inc.
The Village Company will provide a replacement product or refund to any consumer who has proof of purchase, which includes a receipt or a photo of the recalled lot code on the bottom of the bottle. Consumers should discard the product or return the product to The Village Company. If discarding the product, consumers should send an email to LaBellaExtremeSport@TheVillageCompany.com with the date they are discarding the product. Consumers may visit www.LaBellaExtremeSport.comExternal Link Disclaimer for additional instructions.
Consumers with questions may contact the company via our recall hotline at 612-268-2225 from Friday, May 24 – Monday, May 27 between the hours of 9:00am and 9:00pm EST. Starting Tuesday, May 28, consumers may contact customer service at 1-800-699-6852 weekdays between the hours of 9:00am and 6:00pm EST. Consumers may also contact the company via e-mail at LaBellaExtremeSport@TheVillageCompany.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online
Regular Mail or Fax: Download formor call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
Consumers:
1-800--699-6852
LaBellaExtremeSport@TheVillageCompany.com
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March 11, 2019; Claire’s Stores, Inc., Announces Voluntary Recall of Three Make-Up Products
- March 11, 2019
Claire’s Stores, Inc., announced a voluntary recall of three cosmetic products: Claire’s Eye Shadows, Claire’s Compact Powder and Claire’s Contour Palette. We initiated this voluntary recall after testing by the U.S. Food and Drug Administration indicated the possible presence of asbestos fibers in product samples from one lot of each product. Inhalation of asbestos over time has been linked to serious adverse health consequences.
The products are no longer available in stores, but may still be in the homes of consumers. The SKUs/Lots being recalled are:
Claire's Eyeshadows, UPC #888711847165, SKU #84716, Lot No. 08/17
Claire's Compact Powder, UPC #888711839153, SKU #83915, Lot No. 07/15
Claire's Contour Palette, UPC #888711401947, SKU #40194, Lot No. 04/17
The SKUs and UPCs can be found on the price tickets affixed to the products, and all batch numbers are shown on the back panels below the ingredient lists.
All three products were offered for sale between October 2016 and March 2019 and have been removed from the marketplace. They were sold in Claire's stores nationwide and on www.claires.com. External Link DisclaimerAny consumers who have purchased these products should discontinue use and return them to a Claire’s store for a full refund.
To date, Claire’s is not aware of any adverse reactions, injuries or illness caused by the possible presence of asbestos in the recalled products. Claire’s continues to have confidence in the safety and composition of its products and is taking these actions out of an abundance of caution. We are working with FDA to ensure the agency and our customers share that confidence.
Claire’s understands many parents trust and expect us to hold the cosmetics purchased by and for their children to the highest possible safety standards. In the last year, Claire’s switched to talc-free manufacturing for all its cosmetics.
Consumers with questions may contact Claire’s at 800-252-4737, option 2, from 9:30 a.m.-7 p.m. EDT.Company Contact Information
Consumers:
Claire’s
800-252-4737
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December 11, 2018; Kimberly-Clark Announces Voluntary Recall of U by Kotex Sleek Tampons, Regular Absorbency for a quality-related defect.
- December 11, 2018
Description: Kimberly-Clark Announces Voluntary Recall of U by Kotex Sleek Tampons, Regular Absorbency for a quality-related defect involving the unraveling and/or coming apart upon removal, and in some cases causing users to seek medical attention to remove tampon pieces left in the body. There also have been a small number of reports of infections, vaginal irritation, localized vaginal injury, and other symptoms.
Codes: The recall is limited to specific lots of U by Kotex Sleek Tampons, Regular Absorbency, that were manufactured between October 7, 2016 and October 16, 2018 and distributed between October 17, 2016 and October 23, 2018.
Contact: Kimberly-Clarks Consumer Service: 1-888-255-3499
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November 7, 2018; Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions.
- November 07, 2018
Description: Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility. Use of a non-sterile eye drop is potentially vision-threatening due to the risk of an eye infection. Additionally, the pH of the product is relatively high and can cause direct destruction of tissues in the cornea, anterior chamber and deeper structures of the eye which can lead to scarring, glaucoma or vision loss.
Codes: It is packaged in a 15 ml plastic bottle, NDC 7079600115, UPC 7 36972 1679 0.
Contact: Kadesh Inc., 4731 Lincoln Way, Garden Grove, CA 92841.
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September 25, 2018; Eternal Ink Inc. is voluntarily recalling Eternal Ink Tattoo Ink, True Blue Ink due to potential microbial contamination.
- September 25, 2018
Description: Eternal Ink Inc. is voluntarily recalling Eternal Ink Tattoo Ink, True Blue Ink due to potential microbial contamination.
Codes: Eternal Ink Tattoo Ink, 2 fl. oz./60 mL, Blue Ink, Lot #352, Manufactured 12/18/2017; Exp. Date: 12/18/20
Contact: Eternal Ink Inc., 7987 Lochlin Dr., Brighton, MI 48116-8329
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September 25, 2018; Eternal Ink Inc. is voluntarily recalling Eternal Ink Tattoo Ink, Dark Red Ink due to potential microbial contamination.
- September 25, 2018
Description: Eternal Ink Inc. is voluntarily recalling Eternal Ink Tattoo Ink, Dark Red Ink due to potential microbial contamination.
Codes: Eternal Ink Tattoo Ink, 2 fl. oz./60 mL, Red Ink, Lot #352, Manufactured 12/18/2017, Exp. Date: 12/18/20
Contact: Eternal Ink Inc., 7987 Lochlin Dr., Brighton, MI 48116-8329
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September 24, 2018; Essity recalled Tork Foam Soap Extra Mild, because the product tested positive for Burkholderia cepacia (B. cepacia) and exceeded product release limits for bacteria.
- September 24, 2018
Description: Essity recalled Tork Foam Soap Extra Mild, because the product tested positive for Burkholderia cepacia (B. cepacia) and exceeded product release limits for bacteria.
Codes; SKU 401211, 1 liter (33.8 US Fl. Oz.) and 6 bottles per corrugated box case. Class II SKU 401211 EXP SEP19 to EXP JUL20
Contact: Essity, 2929 Arch St., Philadelphia, PA 19104-2857
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September 13, 2018; GoodFibers LLC recalled Royal Family Makeup Remover Wipes, Calming Lavender due to contamination with Psuedomonas aeruginosa.
- September 13, 2018
Description: GoodFibers LLC recalled Royal Family Makeup Remover Wipes, Calming Lavender due to contamination with Psuedomonas aeruginosa.
Codes: UPC 858838007056, 30 Count, Makeup Removing Wipes, in plastic film packaging Class II MFG 08 23 2018.
Contact: GoodFibers LLC., 4949 W Buckeye Rd., Phoenix, AZ 85043-4800
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September 13, 2018; GoodFibers LLC recalled Royal Family Makeup Remover Wipes, Refreshing Cucumber due to contamination with Psuedomonas aeruginosa.
- September 13, 2018
Description: GoodFibers LLC recalled Royal Family Makeup Remover Wipes, Refreshing Cucumber due to contamination with Psuedomonas aeruginosa.
Codes: UPC 858838007063, 30 Count, Makeup Removing Wipes, in plastic film packaging Class II MFG 08 23 2018.
Contact: GoodFibers LLC., 4949 W Buckeye Rd., Phoenix, AZ 85043-4800
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September 13, 2018; GoodFibers LLC recalled Royal Family Makeup Remover Wipes, For All Skin Types due to contamination with Psuedomonas aeruginosa.
- September 13, 2018
Description: GoodFibers LLC recalled Royal Family Makeup Remover Wipes, For All Skin Types due to contamination with Psuedomonas aeruginosa.
Codes: UPC 858838007049, 30 Count, Makeup Removing Wipes, in plastic film packaging Class II MFG 08 23 2018.
Contact: GoodFibers LLC., 4949 W Buckeye Rd., Phoenix, AZ 85043-4800
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August 28, 2018; Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination.
- August 28, 2018
Description: Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination identified as Pseudomonas aeruginosa. Repetitive use of a nasal spray or other nasal product containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or immune-compromised individuals. Similarly, repetitive use of an oral gel product containing a pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, including babies or very young children.
Codes: Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist
Contact: Product Quest Manufacturing LLC at 704-939-4342
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August 22, 2018; Thorton Industries recalled Family wellness Cornstarch baby powder for incorrect ingredient declaration
- August 22, 2018
Description: Thorton Industries recalled Family wellness Cornstarch baby powder for incorrect ingredient declaration. Product has incorrect ingredient declaration, states contains talc but does not contain talc.
Codes: 14oz. plastic bottle, Lot#18142THW
Contact: Thorton Industries, 2000 Ashley Rd., Morris, IL 60450-7900
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July 25, 2018; The Hain Celestial Group, Inc. has recalled Avalon Organics Refreshing Lemon Bath & Shower Gel due to elevated levels of microbiological counts.
- July 25, 2018
Description: The Hain Celestial Group, Inc. has recalled Avalon Organics Refreshing Lemon Bath & Shower Gel due to elevated levels of microbiological counts.
Codes: 12 fl. oz. (AV35185) UPC# 6 54749 35185 7 Class II Lot 8081
Contact: The Hain Celestial Group, Inc., 1111 Marcus Ave., New Hyde Park, NY 11042-1221
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July 25, 2018; The Hain Celestial Group, Inc. has recalled Avalon Organics Nourishing Lavender Bath & Shower Gel due to elevated levels of microbiological counts.
- July 25, 2018
Description: The Hain Celestial Group, Inc. has recalled Avalon Organics Nourishing Lavender Bath & Shower Gel due to elevated levels of microbiological counts.
Codes: 32 fl. oz. (AV35196) UPC# 6 54749 35196 3 Class II Lot 8167
Contact: The Hain Celestial Group, Inc., 1111 Marcus Ave., New Hyde Park, NY 11042-1221
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July 6, 2018; Saje Natural Business Inc. has recalled Splish Splash Gentle Baby Wash due to the potential to be contaminated with Pseudomonas aeruginosa.
- July 06, 2018
Description: Saje Natural Business Inc. has recalled Splish Splash Gentle Baby Wash due to the potential to be contaminated with Pseudomonas aeruginosa.
Codes: 8.5 fl. oz. (Product Code BS701366; SKU 700552) and 1.7 fl. oz. (Product Code BS701370; SKU 700561) bottles. Class II Lot Number 814020 - all expiry dates. Shelf life for lot code is 4/2/2020
Contact: Saje Natural Business Inc., 88 Pender St E Suite 555, Vancouver
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June 26, 2018; Intense Products has initiated a recall of tattoo inks because of microbial organisms (bacillus halosaccharovorans, brachybacterium conglomeratum, and pseudomonas andersonii and pseudomonas balearica) in the inks.
- June 26, 2018
Description: Intense Products has initiated a recall of tattoo inks because of microbial organisms (bacillus halosaccharovorans, brachybacterium conglomeratum, and pseudomonas andersonii and pseudomonas balearica) in the inks.
Codes: Intenze Bright Red Tattoo Ink (Lot SS264), 2 OZ Class II Lot SS264 Bright Red (Lot SS264) and Royal Blue (Lot SS258)
Contact: Intense Products, 215 Nl-17, Rochelle Park, NJ 07662
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June 26, 2018; Intenze Products has initiated a recall of Bright Red and Royal Blue Tattoo Ink because of microbial organisms (bacillus halosaccharovorans, brachybacterium conglomeratum, and pseudomonas andersonii and pseudomonas balearica) in the inks.
- June 26, 2018
Description: Intenze Products has initiated a recall of Bright Red and Royal Blue Tattoo Ink because of microbial organisms (bacillus halosaccharovorans, brachybacterium conglomeratum, and pseudomonas andersonii and pseudomonas balearica) in the inks.
Codes: Intenze Royal Blue Tattoo Ink (Lot SS258) , 2 OZ Class II Lot SS258, Bright Red (Lot SS264) and Royal Blue (Lot SS258)
Contact: Intenze Products, 215 Nl-17, Rochelle Park, NJ 07662
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June 11, 2018; Bath and Body Works has recalled Pure Simplicity Body Acai Berry for possible contamination with Enterobacter aerogenes and/or Enterobacter gergoviae.
- June 11, 2018
Description: Bath and Body Works has recalled Pure Simplicity Body Acai Berry for possible contamination with Enterobacter aerogenes and/or Enterobacter gergoviae.
Codes: Pure Simplicity Body Acai Berry, Class II 7223C3A1, 7223C3B1
Contact: Bath & Body Works, 7 Limited Pkwy East, Reynoldsburg, OH 43068-5304
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June 11, 2018; Bath and Body Works has recalled Pure Simplicity Body Fragrance Free for possible contamination with Enterobacter aerogenes and/or Enterobacter gergoviae.
- June 11, 2018
Description: Bath and Body Works has recalled Pure Simplicity Body Fragrance Free for possible contamination with Enterobacter aerogenes and/or Enterobacter gergoviae.
Codes: Pure Simplicity Body Fragrance Free, 7221C3B1
Contact: Bath & Body Works, 7 Limited Pkwy East, Reynoldsburg, OH 43068-5304
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May 25, 2018; Shadow Holdings, LLC. Issues Voluntary Nationwide Recall of X-Jow and Acne Shave products due to Possible Bacterial Contamination.
- May 25, 2018
Description: Shadow Holdings, LLC. Issues Voluntary Nationwide Recall of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit to the retail level. The products may be contaminated with bacteria. Topical administration of the products could result in potentially serious bacterial infections in immunocompromised individuals.
Codes: Herb-X Solutions X-Jow Pain Gel is used as an external analgesic, which is packaged in 4 oz. and 8 oz. bottles. The United Exchange Acne Shave Moisturizer and Acne Shave Shave Cream with Acne Shield are used as topical acne medications, and are packaged in 3.3 oz. and 5.1 oz. bottles respectively. The United Exchange Acne Shave Shave Kit contains potentially affected units of both the Acne Shave Moisturizer and the Acne Shave Shave Cream with Acne Shield.
Contact: Shadow Holdings at 661-673-8519 Monday – Friday 8am – 5pm., Pacific Daylight Time (PDT).
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May 15, 2018; Solid Ink has recalled Solid Ink Orange (tattoo ink) (Batch #8297) which resulted positive for Bacillus pumilus, Bacillus licheniformis, and Pseudomonas sp.
- May 15, 2018
Description: Solid Ink has recalled Solid Ink Orange (tattoo ink) (Batch #8297) which resulted positive for Bacillus pumilus, Bacillus licheniformis, and Pseudomonas sp.
Codes: Solid Ink Orange (tattoo ink) (Batch #8297), EXP DATE 8/21
Contact: Solid Ink, 16600 NE 54th Ave #6, Miami Gardens, FL 33014
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Eufora BEAUTIFYING ELIXIR BODIFYING CONDITIONER, 1.7 oz. due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: Shadow Holdings DBA Bocchi Labs is recalling Eufora BEAUTIFYING ELIXIR BODIFYING CONDITIONER, 1.7 oz. due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: 1.7 oz. Class II B70821
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Eufora - BEAUTIFYING ELIXIR BODIFYING SHAMPOO, 1.7 oz. and 8.5 oz. due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: Shadow Holdings DBA Bocchi Labs is recalling Eufora - BEAUTIFYING ELIXIR BODIFYING SHAMPOO, 1.7 oz. and 8.5 oz. due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: 1.7 oz. lot B70824; 8.5 oz. lot B70824
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Eufora BEAUTIFYING ELIXIR MOIST INTENSE CONDITIONER, 1.7oz Class II B70830 due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Eufora BEAUTIFYING ELIXIR MOIST INTENSE CONDITIONER, 1.7oz Class II B70830 due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: 1.7oz Class II B70830
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Eufora NOURISH HYDRATING SHAMPOO, 8.45 oz. Class II B70819 due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: Shadow Holdings DBA Bocchi Labs is recalling Eufora NOURISH HYDRATING SHAMPOO, 8.45 oz. Class II B70819 due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: 8.45 oz. Class II B70819
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Eufora NOURISH BODIFYING CONDITIONER, 8.5oz Class II B70821 due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: Shadow Holdings DBA Bocchi Labs is recalling Eufora NOURISH BODIFYING CONDITIONER, 8.5oz Class II B70821 due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: NOURISH BODIFYING CONDITIONER, 8.5oz Class II B70821
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling John Paul Mitchell NEURO REPAIR HEAT CONTROL BLOWOUT PRIMER, 0.85 oz. and 4.7 oz. due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: Shadow Holdings DBA Bocchi Labs is recalling John Paul Mitchell NEURO REPAIR HEAT CONTROL BLOWOUT PRIMER, 0.85 oz. and 4.7 oz. due to potential contamination with Burkholderia cepacia complex (Bcc).
Codes: 85 oz. - lot JPS7HA; 4.7 oz. - lot JPS7HA
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling John Paul Mitchell INVISIBLEWEAR MEMORY SHAPER, due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling John Paul Mitchell INVISIBLEWEAR MEMORY SHAPER, due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: .8.5 oz. Class II JPS7HA
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling John Paul Mitchell NEURO LATHER HEAT CONTROL SHAMPOO, due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling John Paul Mitchell NEURO LATHER HEAT CONTROL SHAMPOO, due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: NEURO LATHER HEAT CONTROL SHAMPOO, 9.2 oz. Class II JPS7HB
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling John Paul Mitchell NEURO LATHER HEAT CONTROL CONDITIONER, due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: Shadow Holdings DBA Bocchi Labs is recalling John Paul Mitchell NEURO LATHER HEAT CONTROL CONDITIONER, due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: 9.2 oz. Class II JPS7HA
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Medline PHYTOPLEX NOURISHING SKIN CREAM, due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: Shadow Holdings DBA Bocchi Labs is recalling Medline PHYTOPLEX NOURISHING SKIN CREAM, due to potential contamination with Burkholderia cepacia complex (Bcc). DA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: PHYTOPLEX NOURISHING SKIN CREAM, 16 oz. Class II M06416; Medline SKU MSC092416
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Medline REMEDY MOISTURIZING BODY LOTION, 16 oz. due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Medline REMEDY MOISTURIZING BODY LOTION, 16 oz. due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: Medline REMEDY MOISTURIZING BODY LOTION, 16 oz., Class II M06416; Medline SKU MSC092416
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Medline PHYTOPLEX HYDRATING CLEANSER SHAMPOO BODY WASH GEL, 2 oz. due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: Shadow Holdings DBA Bocchi Labs is recalling Medline PHYTOPLEX HYDRATING CLEANSER SHAMPOO BODY WASH GEL, 2 oz. due to potential contamination with Burkholderia cepacia complex (Bcc). DA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: PHYTOPLEX HYDRATING CLEANSER SHAMPOO BODY WASH GEL, 2 oz., M07157; Medline SKU MSC092002
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Medline PHYTOPLEX HYDRATING CLEANSER NO RINSE FOAM, 4 oz. and 8 oz. due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: Shadow Holdings DBA Bocchi Labs is recalling Medline PHYTOPLEX HYDRATING CLEANSER NO RINSE FOAM, 4 oz. and 8 oz. due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: Medline PHYTOPLEX HYDRATING CLEANSER NO RINSE FOAM, 4 oz. M07558, M07559, M07560 Medline SKU MSC092104 ; 8 oz. M07839, M07840, M07841, M07842; Medline SKU MSC092108
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Medline HYDRATING CLEANSER SPRAY, 4 oz. due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: Shadow Holdings DBA Bocchi Labs is recalling Medline HYDRATING CLEANSER SPRAY, 4 oz. due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: Medline HYDRATING CLEANSER SPRAY, M06818; Medline SKU MSC092204
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Medline PHYTOPLEX HYDRATING CLEANSER NO RINSE FOAM UNSCENTED, 4 oz. due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: Shadow Holdings DBA Bocchi Labs is recalling Medline PHYTOPLEX HYDRATING CLEANSER NO RINSE FOAM UNSCENTED, 4 oz. due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: PHYTOPLEX HYDRATING CLEANSER NO RINSE FOAM UNSCENTED, 4 oz, M07514; Medline SKU MSC092104UNSC
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Medline PHYTOPLEX HYDRATING CLEANSER SHAMPOO & BODY WASH GEL, 4 oz. and 8 oz. due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: Shadow Holdings DBA Bocchi Labs is recalling Medline PHYTOPLEX HYDRATING CLEANSER SHAMPOO & BODY WASH GEL, 4 oz. and 8 oz. due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: Medline PHYTOPLEX HYDRATING CLEANSER SHAMPOO & BODY WASH GEL, 4 oz. M05879, M07925; Medline SKU MSC092004; 8 oz. M05879, M06135
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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May 8, 2018; Shadow Holdings DBA Bocchi Labs is recalling Medline REMEDY ESSENTIAL CLEANSER NO-RINSE FOAM: 4 oz. and 8 oz. due to potential contamination with Burkholderia cepacia complex (Bcc).
- May 08, 2018
Description: Shadow Holdings DBA Bocchi Labs is recalling Medline REMEDY ESSENTIAL CLEANSER NO-RINSE FOAM: 4 oz. and 8 oz. due to potential contamination with Burkholderia cepacia complex (Bcc). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.
Codes: 4 OZ. M05703; Medline SKU MSC092FBC04; 8 OZ.: m07476 Medline SKU MSC092FBC08
Contact: Shadow Holdings DBA Bocchi Labs, 26421 Ruether Ave., Santa Clarita, CA 91350-2621
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March 29, 2018; MarcasUSA, LLC Issues Voluntary Nationwide Recall of Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide 60g Due to Potential Contamination
- March 29, 2018
Description: MarcasUSA, LLC and Industria Farmacéutica Andromaco, S.A. de C.V. is voluntarily recalling four lots of Pasta De Lassar Andromaco Skin Protectant, 25% zinc oxide to the retail level. FDA analysis of this product confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. The specific lot associated to the positive findings was never sold in the US. However, due to the amount and type of contamination the remaining four lots in the US market are being recalled out of an abundance of caution. Use of the contaminated product could result in an increased risk of infection.
Codes: PASTA DE LASSAR ANDROMACO, Skin Protectant, 25% zinc oxide, Topical cream, 60-gram tube, UPC #851357003004, NDC #75940-111-60
Contact: MarcasUSA by phone at +1-800-428-9489
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January 22, 2018; Divine Living Tooth Brushing Spray recalled for inadmissible dietary and health claims.
- January 22, 2018
Description: Divine Living Tooth Brushing Spray recalled for inadmissible dietary and health claims.
Codes: 4oz (with Active Ingredients: 1 percent Food Grade Hydrogen Peroxide, Purified water, organic aloe vera, and organic essential oils (peppermint, rosemary, cinnamon, eucalyptus, lemon, orange, and clove).
Contact: Divine Living, 20675 County Road I50, West Unity, OH 43570-9519
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December 12, 2017; Radiant Colors Inc. recalled Radiant Colors Victor Portugal Lining Black since it was found to contain Bacillus altitudinis.
- December 12, 2017
Description: Radiant Colors Inc. recalled Radiant Colors Victor Portugal Lining Black since it was found to contain Bacillus altitudinis.
Codes: 1 oz. plastic bottlevLot 003, Exp. 0918
Contact: Radiant Colors, Inc., 7365 Melrose Ave., Los Angeles, CA 90046-7526
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November 14, 2017; Fusion Ink, LLC recalled Royal Blue Glycerin Tattoo Ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to Microbial contamination of tattoo ink.
- November 14, 2017
Description: Fusion Ink, LLC recalled Royal Blue Glycerin Tattoo Ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to Microbial contamination of tattoo ink.
Codes: Best by 04/10/2020
Contact: Fusion Ink, LLC - Texas, 1012 W Broadway St., Winnsboro, TX 75494-2004
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November 14, 2017; Fusion Ink, LLC recalled Light Blue tattoo ink
- November 14, 2017
Description: Fusion Ink, LLC recalled Light Blue tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to Microbial contamination of tattoo ink.
Codes: Best by 07/11/2020
Contact: Fusion Ink, LLC - Texas, 1012 W Broadway St., Winnsboro, TX 75494-2004
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November 14, 2017; Fusion Ink, LLC recalled Pretty purple tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to Microbial contamination of tattoo ink.
- November 14, 2017
Description: Fusion Ink, LLC recalled Pretty purple tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to Microbial contamination of tattoo ink.
Codes: 1oz, 2oz, 4oz, 8oz bottles-Best by 07/11/2020
Contact: Fusion Ink, LLC - Texas, 1012 W Broadway St., Winnsboro, TX 75494-2004
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November 14, 2017; Fusion Ink, LLC recalled Gamma Green tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to Microbial contamination of tattoo ink.
- November 14, 2017
Description: Fusion Ink, LLC recalled Gamma Green tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to Microbial contamination of tattoo ink.
Codes: 1oz, 2oz, 4oz, 8oz bottles- Best by 07/13/2020
Contact: Fusion Ink, LLC - Texas, 1012 W Broadway St., Winnsboro, TX 75494-2004
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November 14, 2017: Fusion Ink, LLC recalled Orange color tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to microbial contamination of tattoo ink.
- November 14, 2017
Description: Fusion Ink, LLC recalled Orange color tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles due to microbial contamination of tattoo ink.
Codes: Ink packaged in 1oz, 2oz, 4oz, 8oz bottles- Best by 04/10/2020
Contact: Fusion Ink, LLC - Texas, 1012 W Broadway St., Winnsboro, TX 75494-2004
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November 8, 2017; Oral Essentials, Inc. recalled Oral Essentials Mouthwash, Original Formula, due to potential for Pseudumonas aeruginosa contamination
- November 08, 2017
Description: Oral Essentials, Inc. recalled Oral Essentials Mouthwash, Original Formula, due to potential for Pseudumonas aeruginosa contamination.
Codes: UPC Code: 60124 00010
Contact: Oral Essentials, Inc., 436 N Roxbury Dr #202, Beverly Hills, CA 90210-5026
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October 25, 2017; Benefit Cosmetics recalled eyebrow products have tested positive for pseudomonas aeruginosa: Gimme Brow 03 Medium BZ BM GEL-UPC: 602004077967; SUF Gimme Brow Mini 03 Medium w/o carton; UPC: 602004083098; UPC: 602004067463; SUF Gimme Brow
- October 25, 2017
Description: Benefit Cosmetics recalled eyebrow products have tested positive for pseudomonas aeruginosa: Gimme Brow 03 Medium BZ BM GEL-UPC: 602004077967; SUF Gimme Brow Mini 03 Medium w/o carton; UPC: 602004083098; UPC: 602004067463; SUF Gimme Brow Medium 03 w/o carton w/FILL UPC:602004081582; SA Gimme Brow 03 Medium Individual Sample BZ BM GEL;UPC: 602004073402. Birchbox 28751 Brow Kit Gimme
Codes: Gimme Brow 03 Medium BZ BM GEL; Mini SKU BM57; UPC: 602004077967; SUF Gimme Brow Mini 03 Medium w/o carton; SKU: BM57SUF; UPC: 602004083098; SKU EC08: UPC: 602004067463; SUF Gimme Brow Medium 03 w/o carton w/FILL SKU EC08SUF; UPC:602004081582; SA Gimme Brow 03 Medium Individual Sample BZ BM GEL; SKU: SA233; UPC: 602004073402. Birchbox 28751 Brow Kit Gimme.
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled eyebrow products have tested positive for pseudomonas aeruginosa: Gimme Brow 01 Light Metalized Mini: SKU: BM74; UPC: 602004089434; Gimme Brow 01 Light BZ BM GEL; SKU: EC07; SKU: 602004067456; SA Gimme Brow 01
- October 25, 2017
Description: Benefit Cosmetics recalled eyebrow products have tested positive for pseudomonas aeruginosa: Gimme Brow 01 Light Metalized Mini: SKU: BM74; UPC: 602004089434; Gimme Brow 01 Light BZ BM GEL; SKU: EC07; SKU: 602004067456; SA Gimme Brow 01 Light Individual Sample BZ BM GEL; SKU: SA232; UPC: 602004073396 Birchbox Brow Kit Gimme Brow 01 Light; SKU: US34, UPC: 602004092465
Codes: Gimme Brow 01 Light Metalized Mini: SKU: BM74; UPC: 602004089434; Gimme Brow 01 Light BZ BM GEL; SKU: EC07; SKU: 602004067456; SA Gimme Brow 01 Light Individual Sample BZ BM GEL; SKU: SA232; UPC: 602004073396 Birchbox Brow Kit Gimme Brow 01 Light; SKU: US34, UPC: 602004092465
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled eyebrow products have tested positive for pseudomonas aeruginosa: Gimme Brow 05 Deep BZ BM GEL; SKU: EC09; UPC: 602004073013; SUF Gimme Brow 05 Deep w/o carton w/FILL; SKU: EC09SUF; UPC: 602004086907; SA Gimme
- October 25, 2017
Description: Benefit Cosmetics recalled eyebrow products have tested positive for pseudomonas aeruginosa: Gimme Brow 05 Deep BZ BM GEL; SKU: EC09; UPC: 602004073013; SUF Gimme Brow 05 Deep w/o carton w/FILL; SKU: EC09SUF; UPC: 602004086907; SA Gimme Brow 05 Deep Individual Sample BZ BM GEL SKU: SA234; UPC: 602004073419; Birchbox 28752 Brow Kit Gimme Brow 05 Deep; SKU: US20, UPC: 602004091918.
Codes: Gimme Brow 05 Deep BZ BM GEL; SKU: EC09; UPC: 602004073013; SUF Gimme Brow 05 Deep w/o carton w/FILL; SKU: EC09SUF; UPC: 602004086907; SA Gimme Brow 05 Deep Individual Sample BZ BM GEL SKU: SA234; UPC: 602004073419; Birchbox 28752 Brow Kit Gimme Brow 05 Deep; SKU: US20, UPC: 602004091918.
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Sunday My Prince Will Come Sephora Situational FM KIT since it tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Sunday My Prince Will Come Sephora Situational FM KIT since it tested positive for pseudomonas aeruginosa.
Codes: SKU: FM71, UPC: 602004081001 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Spring 2017 TS Light Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Spring 2017 TS Light Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN216, UPC: 602004089052 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Spring 2017 TS Medium Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Spring 2017 TS Medium Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN217, UPC: 602004089069 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Spring 2017 TS Deep; Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Spring 2017 TS Deep; Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN218, UPC: 602004089076 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled January TS Light; Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled January TS Light; Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN246, UPC:602004092328 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled January TS Medium; Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled January TS Medium; Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN247, UPC:602004092335 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled January TS Deep: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled January TS Deep: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN248, UPC:602004092342 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Bobbi's June Host Pick Medium: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Bobbi's June Host Pick Medium: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN261, UPC: 602004094773 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Bobbi's June Host Pick Light: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Bobbi's June Host Pick Light: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN260, UPC: 602004094766 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Bobbi's June Host Pick Deep: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Bobbi's June Host Pick Deep: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN262, UPC: 602004094780 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Fall Best in Beauty Set Light: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Fall Best in Beauty Set Light: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN266, UPC: 602004092250 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Fall Best in Beauty Set Medium: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Fall Best in Beauty Set Medium: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN267, UPC: 602004092090 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Fall Best in Beauty Set Deep: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Fall Best in Beauty Set Deep: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN269, UPC: 602004092267 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Gimme Brow 03 & Precisely 03: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Decription: Benefit Cosmetics recalled Gimme Brow 03 & Precisely 03: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN271, UPC: 602004097774 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Gimme Brow 01 & Precisely 02: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa
- October 25, 2017
Description: Benefit Cosmetics recalled Gimme Brow 01 & Precisely 02: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN270, UPC: 602004097767 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Gimme Brow 05 & Precisely 05: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: October 25, 2017; Benefit Cosmetics recalled Gimme Brow 05 & Precisely 05: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN272, UPC: 602004097781 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Gimme Brow Light Duo & Bag: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Gimme Brow Light Duo & Bag: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN273, UPC: 602004097903 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Gimme Brow Medium Duo & Bag: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Gimme Brow Medium Duo & Bag: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN274, UPC: 602004097910 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Gimme Brow Deep Duo & Bag: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Gimme Brow Deep Duo & Bag: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN275, UPC: 602004097927 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Marlo's Fall '17 Host Pick Light: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Marlo's Fall '17 Host Pick Light: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN311, UPC: 602004099389 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Marlo's Fall '17 Host Pick Medium: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Marlo's Fall '17 Host Pick Medium: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN312, UPC: 602004099396 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Marlo's Fall '17 Host Pick Deep: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Marlo's Fall '17 Host Pick Deep: Home Shopping Network since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: HSN313, UPC: 602004099402 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled SD Gimme Brow 01 Light Non Metalized Fun Size since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled SD Gimme Brow 01 Light Non Metalized Fun Size since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: SD84, UPC:602004078285 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled SD Gimme Brow 03 Medium Non Metalized Fun Size since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled SD Gimme Brow 03 Medium Non Metalized Fun Size since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: SD85, UPC:602004078292 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled SD Gimme Brow 05 Deep Non Metalized Fun Size since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled SD Gimme Brow 05 Deep Non Metalized Fun Size since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: SD86, UPC:602004078308 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled SK Pretty Parade Ulta 2017 Anniversary FM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled SK Pretty Parade Ulta 2017 Anniversary FM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: SK24, UPC:602004084347 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled TR Gimme Brow 03 & Go Duo since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled TR Gimme Brow 03 & Go Duo since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TR28, UPC:602004085504 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Golden Gate Glam Holiday 2017 Full Face Kit since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Golden Gate Glam Holiday 2017 Full Face Kit since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT493, UPC:602004085894; Golden Gate Glam Holiday 2017 Full Face Kit US; SKU: TT493US, UPC:602004092410 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Head Over Hills BOB EU Holiday 2017 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Head Over Hills BOB EU Holiday 2017 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT494, UPC:602004085900; Head Over Hills BOB EU Holiday 2017 US; SKU: TT494US; UPC: 602004092670 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Eye Heart SF BOB Macys Holiday 2017 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Eye Heart SF BOB Macys Holiday 2017 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT495, UPC:602004085917 ; Eye Heart SF BOB Macys Holiday 2017 US; SKU: TT495US; UPC: 602004092687 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Glam Francisco BOB UK Holiday 2017 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: October 25, 2017; Benefit Cosmetics recalled Glam Francisco BOB UK Holiday 2017 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT496, UPC: 602004085924 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled TT Cable Car Cuties H'17 BOB Ulta FM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled TT Cable Car Cuties H'17 BOB Ulta FM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT497, UPC: 602004085931; TT Cable Car Cuties H'17 US BOB Ulta FM SET; SKU TT497US; UPC: 602004092731 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled TT Galifornia Love H'17 BOB Ulta FM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled TT Galifornia Love H'17 BOB Ulta FM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT498, UPC: 602004085948; TT Galifornia Love H'17 US BOB Ulta FM SET; SKU TT498US; UPC: 602004092748 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled San Fran Dandy BOB Asia Holiday 2017 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled San Fran Dandy BOB Asia Holiday 2017 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT501, UPC: 602004086532 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled I Left My Heart in Tan Francisco Boots Holiday 2017 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled I Left My Heart in Tan Francisco Boots Holiday 2017 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT505, UPC: 602004086570; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled TT The Great Brownanza Brow Buster 05 Deep H'17 EM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled TT The Great Brownanza Brow Buster 05 Deep H'17 EM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT509, UPC: 602004086877; TT The Great Brownanza Brow Buster 05 Deep H'17 US EM SET; SKU: TT509US; UPC: 602004092366
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled TT The Great Brownanza Brow Buster 03 Medium H'17 EM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled TT The Great Brownanza Brow Buster 03 Medium H'17 EM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT508, UPC: 602004086822; TT The Great Brownanza Brow Buster 03 Medium H'17 US EM SET; SKU: TT508US; UPC: 602004092359 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled TT Benefit Brow Tryouts 03 Medium since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled TT Benefit Brow Tryouts 03 Medium since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT516, UPC:602004089403 ; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled TT Benefit Brow Tryouts 05 Deep since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled TT Benefit Brow Tryouts 05 Deep since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT534, UPC: 602004091499; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Bay-balicious TR Set Holiday 2017 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Bay-balicious TR Set Holiday 2017 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT525, UPC: 602004089847; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled TT Explore with Natural Shade 01 E-Tailer Brow Style EM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa
- October 25, 2017
Description: October 25, 2017; Benefit Cosmetics recalled TT Explore with Natural Shade 01 E-Tailer Brow Style EM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa
Codes: SKU:TT550US , UPC:602004093714 ; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled TT Explore with Natural Shade 03 E-Tailer Brow Style EM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: October 25, 2017; Benefit Cosmetics recalled TT Explore with Natural Shade 03 E-Tailer Brow Style EM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU:TT551US , UPC:602004093721; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled TT Explore with Natural Shade 05 E-Tailer Brow Style EM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: October 25, 2017; Benefit Cosmetics recalled TT Explore with Natural Shade 05 E-Tailer Brow Style EM SET since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU:TT552US , UPC:602004093738; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Beauty Stowaways Sephora Mini Mania Set 2017 US Only, since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: October 25, 2017; Benefit Cosmetics recalled Beauty Stowaways Sephora Mini Mania Set 2017 US Only, since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU:TT571SPH , UPC: 602004094582; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled TT Gimme Brow 01 Light Desert Island US since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled TT Gimme Brow 01 Light Desert Island US since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: ,TTEC07US UPC: 602004095497; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled TT Gimme Brow 03 Medium Desert Island US since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: October 25, 2017; Benefit Cosmetics recalled TT Gimme Brow 03 Medium Desert Island US since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: ,TTEC08US UPC: 602004095503; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled TT Gimme Brow 05 Deep Desert Island US since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled TT Gimme Brow 05 Deep Desert Island US since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: ,TTEC09US UPC: 602004095510; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled US Brow Popup Book Shade 03 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled US Brow Popup Book Shade 03 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: US50, UPC: 602004097835; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled US Brow Popup Book Shade 05 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled US Brow Popup Book Shade 05 since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: US51, UPC: 602004097842; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Beauty School Knockouts Kit since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Beauty School Knockouts Kit since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: TT474 , UPC: 602004078315 Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Gimme Brow 01 Light Metalized Mini since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Gimme Brow 01 Light Metalized Mini since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: SKU: BM74; UPC: 602004089434; Class II All codes
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 25, 2017; Benefit Cosmetics recalled Gimme Brow 05 Deep Metalized Mini, Gimme Brow 05 Metalized Mini w/o carton since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
- October 25, 2017
Description: Benefit Cosmetics recalled Gimme Brow 05 Deep Metalized Mini, Gimme Brow 05 Metalized Mini w/o carton since samples of eyebrow products have tested positive for pseudomonas aeruginosa.
Codes: Gimme Brow 05 Deep Metalized Mini: SKU: BM75; UPC: 602004089441 ; SUF Gimme Brow 05 Metalized Mini w/o carton; SKU: BM75SUF; UPC: 602004091574
Contact: Benefit Cosmetics, 225 Bush St Fl 20, San Francisco, CA 94104-4279
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October 16, 2017; Avlon Industries, Inc. recalled As I am Born Curly Argan Curl Defining Jelly due to the presence of Enterobacter gergoviae.
- October 16, 2017
Description: Avlon Industries, Inc. recalled As I am Born Curly Argan Curl Defining Jelly due to the presence of Enterobacter gergoviae.
Codes: Lot 16J1601
Contact: Avlon Industries, Inc. 1999 N 15th Ave., Melrose Park, IL 60160-1402
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September 13, 2017; Proctor & Gamble Co Recalled Pampers Sensitive Baby Wipes Mega Box for possible contamination with warehouse floor debris.
- September 13, 2017
Description: Proctor & Gamble Co Recalled Pampers Sensitive Baby Wipes Mega Box for possible contamination with warehouse floor debris. Procter & Gamble Distributing LLC as part of an investigation, determined that approximately 3 minutes of product produced on August 25, 2017 was released that may have been contaminated with warehouse floor debris.
Codes: P&G Brand Code: 80287807 Retail UPC: 37000970651 Product Lot Codes 7237184300 ( Product produced on August 25, 2017.)
Contact: Proctor & Gamble Co. 2 Procter and Gamble Plz., Cincinnati, OH 45202-3315
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September 5, 2017; Tween Brands Inc. recalled Just Shine Bronzer Brush due to possible contamination with asbestos.
- September 05, 2017
Description: Tween Brands Inc. recalled Just Shine Bronzer Brush due to possible contamination with asbestos.
Codes: UPC 19052764 Class II Style 192280 3862 1116
Contact: Tween Brands Inc., 8323 Walton Pkwy., New Albany, OH 43054-9522
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September 5, 2017; Tween Brands Inc recalled Just Shine eye shadow palette (5 piece cool) due to possible contamination with asbestos.
- September 05, 2017
Description: Tween Brands Inc recalled Just Shine eye shadow palette (5 piece cool) due to possible contamination with asbestos.
Codes: UPC 19053734 Class II Style 192451 5258 1116 & Style 192451 5282 0217.
Contact: Tween Brands Inc., 8323 Walton Pkwy., New Albany, OH 43054-9522
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September 5, 2017; Tween Brands Inc recalled Just Shine eye shadow palette (5 piece pinks) due to possible contamination with asbestos.
- September 05, 2017
Description: Tween Brands Inc recalled Just Shine eye shadow palette (5 piece pinks) due to possible contamination with asbestos.
Codes: UPC 19053747 Class II Style 192452 5258 1116 & Style 192452 5282 0217.
Contact: Tween Brands Inc., 8323 Walton Pkwy., New Albany, OH 43054-9522
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September 5, 2017; Tween Brands Inc recalled Just Shine eye shadow palette (9 piece eye shadow & glitter cream) due to possible contamination with asbestos.
- September 05, 2017
Description: Tween Brands Inc recalled Just Shine eye shadow palette (9 piece eye shadow & glitter cream) due to possible contamination with asbestos.
Codes: UPC 19052722 Class II Style 192303 5258 1116
Contact: Tween Brands Inc., 8323 Walton Pkwy., New Albany, OH 43054-9522
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September 5, 2017; Tween Brands Inc recalled Just Shine makeup palette (11 piece pinks)due to possible contamination with asbestos.
- September 05, 2017
Description: Tween Brands Inc recalled Just Shine makeup palette (11 piece pinks)due to possible contamination with asbestos.
Codes: UPC 19052706 Class II Style 192297 5282 1116 & Style 192297 5282 0617
Contact: Tween Brands Inc., 8323 Walton Pkwy., New Albany, OH 43054-9522
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September 5, 2017; Tween Brands Inc recalled Just Shine makeup palette (9 piece glitter cream) due to possible contamination with asbestos.
- September 05, 2017
Description: Tween Brands Inc recalled Just Shine makeup palette (9 piece glitter cream) due to possible contamination with asbestos.
Codes: UPC 19052735 Class II Style 192468 5258 1116
Contact: Tween Brands Inc., 8323 Walton Pkwy., New Albany, OH 43054-9522
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September 5, 2017; Tween Brands Inc recalled Just Shine makeup palette (11 piece blues)due to possible contamination with asbestos.
- September 05, 2017
Description: Tween Brands Inc recalled Just Shine makeup palette (11 piece blues)due to possible contamination with asbestos.
Codes: UPC 19052719 Class II Style 192299 5258 1116 & Style 192299 5258 0617
Contact: Tween Brands Inc., 8323 Walton Pkwy., New Albany, OH 43054-9522
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September 5, 2017; Tween Brands Inc recalled Just Shine shimmer powder due to possible contamination with asbestos.
- September 05, 2017
Description: Tween Brands Inc recalled Just Shine shimmer powder due to possible contamination with asbestos.
Codes: UPC 19052777 Class II Style 192307 5258 1116
Contact: Tween Brands Inc., 8323 Walton Pkwy., New Albany, OH 43054-9522
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August 30, 2017; Lucky Mart Inc. Issues Voluntary Nationwide Recall Of Piyanping Anti-Itch Lotion Due to Incorrect Active Ingredient.
- August 30, 2017
Description: Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling. Dexamethasone is a higher potency steroid than hydrocortisone and may have a longer half-life; it could potentially cause serious side effects in patients applying the cream multiple times daily. There is a reasonable probability of any or all of the following side effects of topical steroids which include but are not limited to skin changes (whitening, thinning), adrenal suppression (high blood sugar, weakened immunity, electrolyte imbalances, emotional lability, slowing of growth in children), glaucoma, and cataracts.
Codes: Products are packaged in a 0.67 oz (20g) tube in a paper carton. Lots C14005 (Exp. 03/2017), C16001 (Exp. 12/2018), C16002 (Exp. 12/2018). NDC 68085-8012-4. Piyanping Anti-Itch Lotion was distributed Nationwide in the USA to herbal and ethnic grocery stores. Lot # and Expiration Date can be found on the right side of the box, opposite of the barcode.
Contact: Lucky Mart Inc. by phone at (909) 590-8838
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August 15, 2017; Rockline Industries, Inc., recalled Dude Products Facial Wipe due to complaints of mold on the wipes.
- August 15, 2017
Description: Rockline Industries, Inc., recalled Dude Products Facial Wipe due to complaints of mold on the wipes.
Codes: LOT 17081 25 IT
Contact: Rockline Industries, Inc., 4343 S Taylor Dr., Sheboygan, WI 53081-8485.
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July 21, 2017; BEAUTYCOUNTER VOLUME AND SHAPE SHAMPOO was recalled due the presence of bacteria Pseudomonas aeruginosa at an average level of 108 bacteria per gram of product.
- July 21, 2017
Description: BEAUTYCOUNTER VOLUME AND SHAPE SHAMPOO was recalled due the presence of bacteria Pseudomonas aeruginosa at an average level of 108 bacteria per gram of product.
Codes: The Product was sold individually and as part of the following product sets: " SKU: 7150 Volume & Shape Collection " SKU: 7126 Hair , lot 7F2819.
Contact: Beautycounter, 2803 Colorado Ave., Santa Monica, CA 90404-3613
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June 12, 2017; Beautycounter Nourishing Day Cream/Beautycounter Creme de jour nourrissante was recalled due the presence of bacteria Pluralibacter gergoviae
- June 12, 2017
Description: Beautycounter Nourishing Day Cream/Beautycounter Creme de jour nourrissante was recalled due the presence of bacteria Pluralibacter gergoviae.
Codes: Lot # 1626003 for both sizes, Expiry date 9/19/2019.
Contact: Beautycounter, 2803 Colorado Ave., Santa Monica, CA 90404-3613
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June 9, 2017; Phillips Company Issues Voluntary Worldwide Recall of All Topical Products Due to Concerns of Manufacturing Practices
- June 09, 2017
Description: Phillips Company Issues Voluntary Worldwide Recall of All Topical Products Due to Concerns of Manufacturing Practices. Phillips Company is voluntarily recalling all lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain and LidoMed distributed by Phillips Company, with business offices located in Sun City, Arizona, to the retail level. The products are being recalled after an FDA inspection found significant manufacturing practices that calls into question the safety, identity, strength, quality and purity of unexpired drug products made at the firm during the past three years. Manufacturing practices that are not in adequate control represent the possibility of risk being introduced into the manufacturing process in decreased quality and consistency of the product. These may have an impact on the safety and efficacy of the product posing a risk to patients. To date, no adverse events have been reported.
Codes: All lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain and LidoMed.
Contact: Phillips Company by e-mail (hp@valliant.net) or by phone (580 746 2430) on Monday-Friday, 9 a.m. to 5 p.m. Central time.
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May 30, 2017; Bymm Corporation DBA Kleancolor is recalling Kleancolor Frameous Lash & Brow, CLEAR LASH AND BROW MASCARA since FDA sampling found mold to be present in the product at levels above the regulatory limits for eye-area products.
- May 30, 2017
Description: Bymm Corporation DBA Kleancolor is recalling Kleancolor Frameous Lash & Brow, CLEAR LASH AND BROW MASCARA since FDA sampling found mold to be present in the product at levels above the regulatory limits for eye-area products.
Codes: Item number: MS1810 UPC Codes: 8-10236-00810-3; Made in China Class II LOT NUMBER: LLH510A.
Contact: Bymm Corporation DBA Kleancolor, 12801 Busch Pl., Santa Fe Springs, CA 90670-3023
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May 12, 2017; The Honest Company is recalling Honest Wipes due to the possible presence of mold.
- May 12, 2017
Description: The Honest Company is recalling Honest Wipes due to the possible presence of mold.
Codes: UPC 0817810011276, 0816645024079, 0817810011276 -72 count packages, UPC 0817810011863, 7000000011863, 0816645023584, 0816645023591 -288 count packages, UPC 0817810014680 -576 count packages, UPC 0817810028540.
Contact: The Honest Company, Inc., 12130 Millennium, Playa Vista, CA 90094-2819
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April 20, 2017; Jusuru International is recalling Stromaderm Age-Defying Serum, 1 fluid ounce jar because the product may contain microorganisms that may present a potential health hazard.
- April 20, 2017
Description: Jusuru International is recalling Stromaderm Age-Defying Serum, 1 fluid ounce jar because the product may contain microorganisms that may present a potential health hazard.
Codes: Item number: 400600. Packaged in Glass jar with glass dropper in a unit carton. Sold as individual units, Class II Lot 3925 Expiration Date: 10/2018 Lot 3785 Expiration Date: 5/2018.
Contact: Jusuru International, 1250 N Red Gum St., Anaheim, CA 92806-1820
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April 12, 2017; Santee Cosmetics recalled Santee 30 Aquamarine Eye Pencil due to non-permitted color additive D&C Red No. 19 (Rhodamine B).
- April 12, 2017
Description: Santee Cosmetics recalled Santee 30 Aquamarine Eye Pencil due to non-permitted color additive D&C Red No. 19 (Rhodamine B).
Codes: UPC# 849609004848 Class II N/A - Not Coded. ( Ship date: 12/22/2015)
Contact: Santee Cosmetics, 13202 Estrella Ave., Gardena, CA 90248-1520
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January 6, 2017; The Honest Company, Inc. recalled The Honest Co. Organic Baby Powder due to potential microbial contamination.
- January 06, 2017
Description: The Honest Company, Inc. recalled The Honest Co. Organic Baby Powder due to potential microbial contamination.
Codes: Net Wt. 4.0 oz. (113 g) UPC Code: 817810014529 Class II All lots.
Contact: The Honest Company, Inc., 12130 Millennium, Playa Vista, CA 90094-2819
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January 6, 2017; The Honest Company, Inc. recalled The Honest Co. Diapering Essentials due to potential microbial contamination.
- January 06, 2017
Description: The Honest Company, Inc. recalled The Honest Co. Diapering Essentials due to potential microbial contamination.
Codes: UPC Code: 0817810027185 Containing Organic Baby Powder Net Wt. 4.0 oz. (113 g) Class II All lots.
Contact: The Honest Company, Inc., 12130 Millennium, Playa Vista, CA 90094-2819
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January 5, 2017; Avlon Industries, Inc. recalled KeraCare Hydrating Detangling Shampoo, Sulfate-free due to the presence of Enterobacter cloacae.
- January 05, 2017
Description: Avlon Industries, Inc. recalled KeraCare Hydrating Detangling Shampoo, Sulfate-free due to the presence of Enterobacter cloacae.
Codes: UPC: 9670838012, Item #53227; UPC: 9670833053, Item #53943 Class II Lot 16G1503 and Lot 16K3l03
Contact: Avlon Industries, Inc. 1999 N 15th Ave., Melrose Park, IL 60160-1402
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December 22, 2016; The Goat Farm recalled Soothing Goat Milk Bath Soak; The Goat Farm- Lavender, 16 oz. (453g) glass jar due to a complaint that a jar of bath soak burst, shattering the glass.
- December 22, 2016
Description: The Goat Farm recalled Soothing Goat Milk Bath Soak; The Goat Farm- Lavender, 16 oz. (453g) glass jar due to a complaint that a jar of bath soak burst, shattering the glass.
Codes: The Goat Farm- Lavender, 16 oz. (453g) glass jar.
Contact: The Goat Farm, 1200 Ludwig Ave., Santa Rosa, CA 95407-7308
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November 7, 2016; Balanced Guru recalled Balanced Guru Astringent Masque, Organic Citrus and Kelp Facial Masque.
- November 07, 2016
Description: Balanced Guru recalled Balanced Guru Astringent Masque, Organic Citrus and Kelp Facial Masque due to Microbial contamination.
Codes: Sold as 4 oz. and 1 oz. m Class II Lot No. 7755115, 7779115.
Contact: Balanced Guru, 5030 Champion Blvd Ste G11 # 254., Boca Raton, FL 33496-2477
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November 7, 2016; Balanced Guru recalled Balanced Guru Antioxidant Masque, Organic Spiced Up Berries Antioxidant Facial Masque.
- November 07, 2016
Description: Balanced Guru recalled Balanced Guru Antioxidant Masque, Organic Spiced Up Berries Antioxidant Facial Masque due to Microbial contamination.
Codes: Sold as 4 oz. and 1 oz. Class II Lot 7854115
Contact: Balanced Guru, 5030 Champion Blvd Ste G11 # 254., Boca Raton, FL 33496-2477
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November 7, 2016; Balanced Guru recalled Balanced Guru Moisturizing Masque, Organic Aloe, Lotus & Chamomile due to Microbial contamination.
- November 07, 2016
Description: Balanced Guru recalled Balanced Guru Moisturizing Masque, Organic Aloe, Lotus & Chamomile due to Microbial contamination.
Codes: Sold as 8 oz., 4 oz., and 1 oz.. Class II Lot 8354056
Contact: Balanced Guru, 5030 Champion Blvd Ste G11 # 254., Boca Raton, FL 33496-2477
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September 7, 2016; United Exchange Corp Issues Voluntary Nationwide Recall of Family Care Brand Eye Wash Due to Microbial Contamination
- September 07, 2016
Description: United Exchange Corp. Cerritos, CA, United Exchange Corp. is voluntarily recalling the following lots of Family Care Eye Wash 4 oz due to microbial contamination. These products consist of a purified water solution. Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight threatening eye infection. Eye Wash/Eye Irrigation Solution is used to flush the eye to relieve irritation, stinging, or itching by removing foreign material such as air pollutants or chlorinated water. It is packaged in 4 oz (118mL) bottles. Family Care Eye Wash was distributed nationwide to wholesale and retail facilities. The company learned of the potential issue through the receipt of a product complaint regarding the product. No illnesses have been reported to date.
United Exchange Corp. is notifying its distributors and customers by recall letter and is arranging for return or disposal of all recalled products. Consumers and businesses that have product which is being recalled should stop using and selling them immediately.
Lot# Expiration UPC Number
G15901 07/31/2018 780707005828
G15902 07/31/2018 780707005828
G15903 07/31/2018 780707005828
G15904 07/31/2018 780707005828
G16909 05/30/2019 780707005828
Contact: Consumers with questions regarding this recall should contact the Customer Service Department at 800-814-8028, available Monday through Friday from 8:30 am to 5:30 pm (Pacific Time). Consumers can contact their physician or healthcare provider if they have additional questions about this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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September 6, 2016; United Exchange Corp. Issues Voluntary Nationwide Recall of Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories Due to Microbial Contamination
- September 06, 2016
Description: United Exchange Corp. of Cerritos, CA, a primary source vendor of the Rugby-branded Eye Irrigating Solution and Major-branded Eye Wash, is voluntarily recalling those lots and expiration dates described in the attached table due to microbial contamination. These products consist of a purified water solution. Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection. As part of its commitment to patient safety, Rugby Laboratories and Major Pharmaceuticals are working with United Exchange, Corp. to notify customers who may be in possession of either Rugby Eye Irrigating Solution NDC 0536-1083-97 or Major Eye Wash NDC 0904-6491-20; for those lots and expiration dates listed in the attached table. Eye Wash/Eye Irrigating Solution is used to flush the eye to relieve irritation, stinging, or itching by removing foreign material such as air pollutants or chlorinated water. It is packaged in 4 oz (118mL) bottles. Rugby-branded Eye Irrigating Solution and Major-branded Eye Wash were distributed nationwide to wholesale and retail facilities including hospitals and pharmacies. The company learned of the potential issue through the receipt of a product complaint regarding this product.
United Exchange Corp. is notifying its distributors and customers by recall letter and is arranging for return of all recalled products. Consumers, pharmacies, and healthcare facilities that have product which is being recalled should stop using and dispensing them immediately.
Contact: Consumers with questions regarding this recall should contact Rugby Customer Support Department at 1-800-645-2158, available Monday through Friday 8a – 8p EST. Consumers can contact their physician or healthcare provider if they have additional questions about this product.
This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration.
Product Description NDC Number Lot Number Expiration Date
Major EyeWash 0904-6491-20 G15905 2018.10
Major EyeWash 0904-6491-20 G15906 2018.10
Major EyeWash 0904-6491-20 G15907 2018.10
Major EyeWash 0904-6491-20 G15910 2018.11
Major EyeWash 0904-6491-20 G15911 2018.11
Major EyeWash 0904-6491-20 G15912 2018.11
Major EyeWash 0904-6491-20 G16901 2019.01
Major EyeWash 0904-6491-20 G16902 2019.01
Major EyeWash 0904-6491-20 G16903 2019.01
Major EyeWash 0904-6491-20 G16905 2019.02
Major EyeWash 0904-6491-20 G16906 2019.02
Major EyeWash 0904-6491-20 G16907 2019.02
Major EyeWash 0904-6491-20 G16910 2019.03
Major EyeWash 0904-6491-20 G16911 2019.03
Rugby EyeWash 0536-1083-97 G15908 2018.10
Rugby EyeWash 0536-1083-97 G15909 2018.11
Rugby EyeWash 0536-1083-97 G16904 2019.01
Rugby EyeWash 0536-1083-97 G16908 2019.02
Rugby EyeWash 0536-1083-97 G16912 2019.03
Rugby EyeWash 0536-1083-97 G16913 2019.03
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September 1, 2016; Frontier Natural Products CO-OP recalled Aura Cacia Relaxing Lavender Milk and Oat Bath packages that tested high for microbial contamination.
- September 01, 2016
Description: Frontier Natural Products CO-OP recalled Aura Cacia Relaxing Lavender Milk and Oat Bath packages that tested high for microbial contamination.
Codes: 9.75 oz plastic jars UPC 0-51381-90317-6,1.75 oz foil pouches UPC 0-51381-90307-7, and 49.6 g foil pouches (with Canadian labeling) UPC 0-51381-30307-5, Class II 5296, 5289, and 5281.
Contact: Frontier Natural Products CO-OP, 3021 78th St., Norway, IA 52318-9520
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August 24, 2016; Sensible Organics, Inc. decided to voluntarily recall Nourish Organic Renewing & Cooling Eye Treatment due to samples that were tested positive for microbes.
- August 24, 2016
Description: Sensible Organics, Inc. decided to voluntarily recall Nourish Organic Renewing & Cooling Eye Treatment due to samples that were tested positive for microbes.
Codes: Nourish Organic Renewing & Cooling Eye Treatment 0.5 FL. oz/15 mL, Class II Lot # G06216
Contact: Sensible Organics, Inc., 3740 W 4th Ave., Beaver Falls, PA 15010-1904
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August 19, 2016; Honeywell Issues Voluntary Nationwide Recall Of One Lot Of Eyesaline Eyewash Solution Due To Microbial Contamination
- August 19, 2016
Description: Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury. Although no injuries have been reported and we have not found any contamination in our batch testing, the voluntary recall is a precautionary measure due to a low risk of product contamination with Klebsiella pneumoniae. Although found in the normal flora of the mouth and skin, if the contaminant were present in a bottle, there is a potential for it to result in infections that may be sight-threatening. Eyesaline Eyewash is sold through industrial sales distributors. Approximately 9,700 32-ounce bottles with lot number F16091-61 are subject to recall. No other lot number of the product is subject to this recall. All of Honeywells distributors who received this lot have been notified by phone, e-mail and certified mail, and have been instructed to notify their customers. See instructions below on how to find the lot number to determine if your supply is covered by this voluntary recall. Distributors must stop distribution of the affected product and return it to Honeywell for credit or replacement. Commercial-industrial users of the product should also check whether their Eyesaline Eyewash is subject to recall. If it is, customers should stop using the solution and contact their distributor for replacement or credit.
The affected product and lot number can be identified as follows:
Product: 32 ounce Eyesaline Eyewash
Lot number: F16091-61 (no other lot number is subject to recall)
The lot number can be found on the outside of the product case, shown at left, and on individual bottles, as shown on the right below.
Contact: Customers with questions regarding this recall can contact their distributor or Honeywell Customer Care at 1-800-430-5490, Monday – Friday, and 8:00 am – 6:30 pm EST. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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August 19, 2016; Sage Products LLC. is recalling Incontinence Clean-Up Cloths with dimethicone and aloe, Fragrance-Free
- August 19, 2016
Description: Sage Products LLC. is recalling Incontinence Clean-Up Cloths with dimethicone and aloe, Fragrance-Free due to potential contamination with the bacteria, Burkholderia cepacia.
Codes: Product Code 7505, 8 cloths per package, 30 packages per case Class I Lot # 52588 , Lot # 52596 , Lot # 52603 , Lot # 52607 , Lot # 53401 , Lot # 53425 , Lot # 54432 , Lot # 55892 . No expiration dates.
Contact: Sage Products LLC., 3909 3 Oaks Rd., Cary, IL 60013-1804
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August 19, 2016; Sage Products LLC is recalling M-Care Meatal Cleansing Cloths for the Foley Catheterized Patient due to potential contamination with the bacteria, Burkholderia cepacia.
- August 19, 2016
Description: Sage Products LLC is recalling M-Care Meatal Cleansing Cloths for the Foley Catheterized Patient due to potential contamination with the bacteria, Burkholderia cepacia.
Codes: a) M-CARE CLEANSING CLOTH 2-PACK, 168 packages per case, Product Code 7952 b) M-CARE CLEANSING CLOTH 4 2-PACKS, 36 packages per case, Product Code 7954 Class I a) Lot Numbers 46651, 47524, 49247, 49782, 50894, 50899, 50904, 51181, 52169, 53283, 54171, 54956, 55721, and 56302. b) Lot Numbers 47528, 48233, 51197, 52174, 53297, 54189, 55754, 56327, 47851, 47880, 47940, 48497, 51512, 52339, 52381, 52386, 52424, 53200, 54026, 54852, 55337, 55739, 56205.
Contact: Sage Products LLC., 3909 3 Oaks Rd., Cary, IL 60013-1804
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August 19, 2016; Sage Products LLC. recalled Comfort (Essential) Bath Cleansing Washcloths due to potential contamination with the bacteria, Burkholderia cepacia.
- August 19, 2016
Description: Sage Products LLC. recalled Comfort (Essential) Bath Cleansing Washcloths due to potential contamination with the bacteria, Burkholderia cepacia.
Codes: a) ESSENTIAL BATH 8-PACK, Fragrance Free, 60 packages per case, Product Code 7803 b) Dignity Health ESSENTIAL BATH 8-PACK, Fragrance Free, 60 packages per case, Product Code 7805 c) COMFORT ESSENTIAL BATH 5-PACK, 84 packages per case, Product Code 7855 d) ESSENTIAL BATH 5-PACK, Fragrance Free, 84 packages per case, more... Class I a) ESSENTIAL BATH 8-PACK, Product Code 7803 b) ESSENTIAL BATH 8-PACK, Product Code 7805 c) COMFORT BATH 5-PACK, Product Code 7855 d) ESSENTIAL BATH 5-PACK, Product Code 7856 e) COMFORT BATH 8-PACK, Product Code 7903.
Contact: Sage Products LLC., 3909 3 Oaks Rd., Cary, IL 60013-1804
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August 19, 2016; Sage Products LLC recalled Comfort (Deodorant) Bath Cleansing Washcloths due to potential contamination with the bacteria, Burkholderia cepacia.
- August 19, 2016
Description: Sage Products LLC recalled Comfort (Deodorant) Bath Cleansing Washcloths due to potential contamination with the bacteria, Burkholderia cepacia.
Codes: c) DEODORANT BATH 5-PACK, 84 packages per case, Product Code 7815 d) DEODORANT BATH 8-PACK, 60 packages per case, Product Code 7818 i) DEODORANT BATH 8-PACK, 44 packages per case, Product Code 7942 j) DEODORANT CLEAN-UP BATH 3-PACK, 100 packages per case, Product Code 7943
Contact: Sage Products LLC., 3909 3 Oaks Rd., Cary, IL 60013-1804
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August 8, 2016; Cleanlife Products LLC. is Recalling Cardinal Health Shampoo Cap Fragrance Free.
- August 08, 2016
Description: Cleanlife Products LLC. is Recalling Cardinal Health Shampoo Cap Fragrance Free. due to cladosporium (mold).
Codes: 1 unit per package, 30 packages per case. Class II 004316, 005316, 018316, 019316, 020316, 021316, 022316, 062316, 063316, 064316, 067316, 068316, 090316, 091316, 092316, 095316, 096316, 097316, 128415, 131415, 132415, 133415, 134415, 153316, 154316, 155316, 158316, 159316, 160316, 166316, 167316, 168316, 169316, 172316, 281315, 282315, 285315, 286315, 317315, 320315, 321315, 322315, 323315, 362315, 363315, 364315
Contact: Cleanlife Products LLC., 868 Pleasant Valley Dr., Springboro, OH 45066-1159
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August 2, 2016; Balanced Guru is recalling Balanced Guru Calming Masque, Organic Calendula & Echinacea Facial Masque which tested positive for microbial contamination.
- August 02, 2016
Description: Balanced Guru is recalling Balanced Guru Calming Masque, Organic Calendula & Echinacea Facial Masque which tested positive for microbial contamination.
Codes: 4 oz and 1 oz. Class II, Lot code 7855115. No expiration date.
Contact: Balanced Guru, 5030 Champion Blvd Ste G11 # 254, Boca Raton, FL 33496-2477
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July 1, 2016; NOW Foods Rejuvenating Clay Masks Total Viable Count (TVC) test result exceeded specification; microorganisms were identified as Saccharomyces cerevisiae and Streptococcus sanguinis.
- July 01, 2016
Description: Rejuvenating clay mask 5 oz tube labeled in part, "NOW Solutions, Rejuvenating Clay Mask, Contains clinically tested sepilift DPHP & Alpaflor Gigawhite to support tightening & brightening effectiveness, paraben free". The package is a white 5 oz box with grey and purple lettering. NOW Foods Rejuvenating Clay Masks Total Viable Count (TVC) test result exceeded specification; microorganisms were identified as Saccharomyces cerevisiae and Streptococcus sanguinis.
Code Information: NOW Product #: 8024 NOW Lot#: 1958257 NOW Batch #: 575948 Contract Mfg. Lot#: 25483
Contact: NOW Foods. 395 Glen Ellyn Rd., Bloomingdale, IL 60108-217
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June 2, 2016; Arbonne is Recalling Eclipse (Black) & Arbor (Brown) Liquid Eyeliner due to Staphylococcus saprophyticus, Staphylococcus lentus, and Staphylococcus xylosis.
- June 02, 2016
Description: Arbonne is recalling Eclipse (Black) & Arbor (Brown) liquid eyeliner due to Staphylococcus saprophyticus, Staphylococcus lentus, and Staphylococcus xylosis.
Code Information: Lot No. 1196, 3535, 3555
Contact: Arbonne International, 9400 Jeronimo Rd., Irvine, CA 92618-1907
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April 18, 2016; Rockline Industries, Inc. Recalls Publix Hypoallergenic Make-up Remover Cleansing Towelette.
- April 18, 2016
Description: Rockline is recalling 2 lots of Publix 25 ct Hypoallergenic Makeup Remover Cleansing Towelettes because it does not contain the correct amount of an ingredient which assures the product's full shelf life.
Codes: 7.2 in. x 7.4 in. 25 Pre-Moistened Towelettes per box. UPC 41415-09775. Distributed by Publix Super Markets, Inc., Lakeland, FL 33802 Class III Lots: 15286 and 15287.
Contact: Rockline Industries, Inc., 1113 Maryland Ave., Sheboygan, WI 53081-4963
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April 13, 2016; Product Description: Radha Peppermint Oil and Majestic Pure Cosmeceuticals Peppermint Essential Oil Products by Private Label Cosmetics Corp. are marked as a "Pure" and contain undeclared Diethyl phthalate.
- April 13, 2016
Description: PEPPERMINT ESSENTIAL OIL repacked into the following: 1) Radha Peppermint Oil, 100% Pure & Natural Peppermint Essential Oil Premium Therapeutic Grade, 4 Fl oz (120 ml), UPC 0 784672901284, Distributed by Radha Beauty 651 Addison St. Berkeley, CA 94710, 2) MAJESTIC PURE COSMECEUTICALS Peppermint essential oil 100% Pure & Natural are marked as a "Pure" and contains undeclared Diethyl phthalate.
Contact: Private Label Cosmetics Corp., 111e Trade Zone Ct., Ronkonkoma, NY 11779-7368
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January 21, 2016; ULTRA Washcloths are to be Recalled by Rockline Industries, Inc., due to Potential Product Spoilage.
- January 21, 2016
Description: ULTRA Washcloths are to be Recalled by Rockline Industries, Inc., due to Potential Product Spoilage.
Products: ULTRA Washcloths- 48 count wipes per pack; ULTRA Washcloths Scent Free - 48 count wipes per pack; Ultra Flush Washcloths - 48 count wipes per pack; ULTRA Adult Wipe - 48 count wipes per pack. All packaged in flexible plastic.
Contact: Rockline Industries, Inc., 4343 S Taylor Dr., Sheboygan, WI 53081-8485
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January 11, 2016; Genosco dba Kleancolor is recalling Kleancolor Lash Bow-Tux Volumizing Mascara because of potential Bacillus cereus, Staphylococcus epidermidis, and Staphylococcus warneri contamination
- January 11, 2016
Description: Genosco dba Kleancolor is recalling Kleancolor Lash Bow-Tux Volumizing Mascara because of potential Bacillus cereus, Staphylococcus epidermidis, and Staphylococcus warneri contamination. Codes: LOT NUMBER: GMX414A Item number: MS1878
Contact: Genosco DBA Kleancolor, 12801 Busch Pl., Santa Fe Springs, CA 90670-3023
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December 4, 2015; Santee Cosmetics is recalling Santee Diamond Color Mascara because it has the potential to be contaminated with mold, Bacillus lentus, Pseudomonas putida, and Achromobacter xylosoxidans.
- December 04, 2015
Description: Santee Cosmetics is recalling Santee Diamond Color Mascara because it has the potential to be contaminated with mold, Bacillus lentus, Pseudomonas putida, and Achromobacter xylosoxidans.
Product: SANTEE Diamond Color Mascara, Item No. ST081, Net Wt. 10g Product Measurements: 5.5 x 1 x 1. Code Information: UPC 849609004381
Contact: Santee Cosmetics, 13202 Estrella Ave, Gardena, CA 90248-1520
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October 26, 2015; Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products Due to Microbial Contamination from Bacteria.
- October 26, 2015
Description: Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria.
Code Information: Lot 1509; Batch #s: 1525811231, 1526514019
Contact: Gilchrist & Soames, 425 E Perry Rd Suite 150, Plainfield, IN 46168-7620
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October 26, 2015; Gilchrist & Soames initiated a voluntary recall of certain Hyatt Regency Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria.
- October 26, 2015
Description: Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria.
Code Information: Item #: B230SH30ML; Lot 1509; Batch #s: 1516624083 1521121109 1525514144 1525514105 1525514144; Lot # 1506, Batch #s: 1515321093 1516221033 1516221144 1516224021 1514722696 1516224082 1516224083
Contact: Gilchrist & Soames, 2425 E Perry Rd Suite 150, Plainfield, IN 46168-762
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October 26, 2015; Gilchrist & Soames Initiated a Voluntary Recall of Certain Verde Collection Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to Microbial Contamination from Bacteria
- October 26, 2015
Description: Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria.
Code Information: Item #: B300CD010; Lot 1509; Batch #s: 1526401438 & 1526401841
Contact: Gilchrist & Soames, 2425 E Perry Rd Suite 150, Plainfield, IN 46168-7620
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October 26, 2015; Gilchrist & Soames Initiated a Voluntary Rcall of Certain EE Spa Shampoo, Body Lotion, Conditioner, and Shower Gel Products Produced from June 2015 September 2015 due to Microbial Contamination from Bacteria.
- October 26, 2015
Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria.
Code Information: Item #: B151SH30ML; Lot 1509; Batch #s: 1517524028, 1524012152, 1524012068 & Lot #s: 1506, Batch #s: 1515511218 1516711206
Contact: Gilchrist & Soames, 2425 E Perry Rd Suite 150, Plainfield, IN 46168-7620
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October 26, 2015; Gilchrist & Soames Initiated a Voluntary Recall of Certain Mohonk Shampoo, Body Lotion, Conditioner, and Shower Gel Products Produced from June 2015 September 2015 due to Microbial Contamination from Bacteria.
- October 26, 2015
Description: Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria.
Contact: Gilchrist & Soames, 2425 E Perry Rd Suite 150, Plainfield, IN 46168-7620
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October 26, 2015; Gilchrist & Soames Initiated a Voluntary Recall of Certain Neil George Shampoo, Body Lotion, Conditioner, and Shower Gel Products Produced from June 2015 September 2015 due to Microbial Contamination from Bacteria.
- October 26, 2015
Description: Gilchrist & Soames initiated a voluntary recall of certain Shampoo, Body Lotion, Conditioner, and Shower Gel Products produced from June 2015 September 2015 due to microbial contamination from bacteria.
Product: Neil George 50ml Body Wash.
Contact: Gilchrist & Soames, 2425 E Perry Rd Suite 150, Plainfield, IN 46168-7620
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October 6, 2015; Aplicare, Inc., Recalled Castile Soap Towelette for Contamination with Nesterenkonia lacusekhoensis.
- October 06, 2015
Description: Aplicare, Inc. Recalls Castile Soap Towelette.
Codes: (SKU T-3112-1S and SKU T-30120-1S Class II SKU: T-3112-15: 60228, 60503, 60768, 61207, 60229, 60504, 60786, 61208, 60230, 60505, 60787, 61390, 60324, 60506, 60788, 61521, 60325, 60521, 60942, 61522, 60326, 60522, 60943, 61691, 60327, 60523, 61102, 60328, 60767, 61103 SKU: T-3012-15: 60221, 60524, 60865, 61436, 6159
Reason for Recall: Product is contaminated with Nesterenkonia lacusekhoensis.
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August 14, 2015; Josie Maran Cosmetics, LLC., is Recalling Josie Maran Argan Oil Face Cream due to Preservative Issues and Potential Enterobacter Gergoviae Contamination.
- August 14, 2015
Description: Josie Maran Cosmetics, LLC is recalling Josie Maran Argan Oil Face Cream due to specifications and standards for preservative issues and potential Enterobacter gergoviae contamination.
Code Information:15126-E Batch of recalled Kits 15149J Batch of recalled Packettes Lot codes: 5112-A 5113-A 5115-A 5117-A 5118-A 5114-A 5107-A 5111-A 5106-A 5110-A 5119-A 5131-A 5132-A 5132-B 5140-A 5141-A 5145-A 5147-A 5147-B 5154-A 5154-B 5155-A 5155-B 5162-A 5162-B 5263-A 5163-A 5166-A 5169-A 5188-A 5189-A
Contact: Josie Maran Cosmetics, 6161 Sabta Monica Blvd., Hollywood, CA 90038
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August 11, 2015; Delta Brands Inc., Recalls My Fair Baby Brand Baby Wipes, Blue package, Item No. 10485-24, 80 Baby Wipes Found to be Contaminated with Bacteria.
- August 11, 2015
Description: The imported baby wipes were found to be contaminated with bacteria based on FDA sampling and analysis.
Contact: Delta Brands Inc., 1890 Palmer Ave., Larchmont, NY 10538-3059
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August 4, 2015; Voluntary Nationwide Recall Of Grey Wash Tattoo Inks And Tattoo Kits by Thousand Virgins Corp Due To Microbial Contamination
- August 04, 2015
FOR IMMEDIATE RELEASE – August 4, 2015 – Miami (City of Industry), Florida – A Thousand Virgins Corp. in Miami (City of Industry), FL is recalling all lots of tattoo Inks described below due to microbiological contamination. A Thousand Virgins grey wash inks; G1, G2 and G3, that are labeled with Lot #129, and bearing the expiration date: 1/16, revealed contamination with Mycobacterium chelonae, Microbacteriumorganisms, and the molds Cryptococcus albidus and members of the Penicilliumgenus. Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection. The recalled products are described below:
Recalled Tattoo Inks (Sold in kits):
Brand:
Code:
Size:
Grey color shades G1,G2,G3
A Thousand Virgins
Grey Wash System
Lot No. 129
Expiration date: 01/16
2oz and 4oz bottles
The inks were manufactured, sold and distributed by A Thousand Virgins Corp. The G1, G2 and G3 grey wash tattoo inks were distributed nationwide and may be available for sale from international and online distributors.
As of today's date, there is no laboratory evidence matching microorganisms isolated from A Thousand Virgins tattoo inks to known cases of infection.
FDA Laboratory testing has found microbial contamination in the inks. Potentially pathogenic organisms were isolated and identified by the FDA.
This recall is being made with the knowledge of the US Food and Drug Administration. Consumers with any questions should contact us at 1-866-829-4659 from Monday to Friday between the hours of 9am to 5pm EST.
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July 31, 2015; Centurion Medical Products Recalled Specific Lots of Mouth Care Convenience Kits due to a Supplier Recall of the Biotene Toothpaste for Possible Wood Fragments.
- July 31, 2015
Description: Centurion Medical Products initiated a voluntary recall of specific lots of their mouth care convenience kits due to a supplier recall of the Biotene Toothpaste for possible wood fragments.
Code Information:
Centurion Code: BTP75, Material Number: MC440, Batch #s & Exp.; 2014081190& 06/2016; 2014102290 & 06/2016; 2014111090 & 09/2016; 2015012290 & 03/2017; 2015040690 & 06/2016; 2015061590 & 05/2016; 2015070390 & 02/2017; 2015072090 & 03/2017. Material No. MC480, Batch # & Exp.: 2014091890 06/2016 2015061590 & 03/2017; 2015071590 & 03/2017.
Contact: Centurion Medical Products Corporation. 100 Centurion Way, Williamston, MI 48895-9086
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July 22, 2015; Mentality Cosmetics is recalling Mentality Nail Polish.
- July 22, 2015
Description: Mentality Cosmetics is recalling Mentality Nail Polish that were sold from 4/22/15 through 6/19/15 due to problematic batches that were manufactured with Arminex International nail polish bases.
Codes: Mentality Nail Polish 0.5 oz/15 ml, all colors. All nail polish produced in the following packaging- Round bottle, black cap, white screen printed logo Round bottle, black cap, black screen printed logo Round bottle, black cap, white or clear vinyl label with either 5 Free, Matte, Gloss, Glaze, Texture, or Opaque. Lot numbers were not assigned. These bottles were small batch-colored, hand-mixed, hand poured items. Official recall includes product sold April 2015 to June 2015.
Contact: Mentality Cosmetics, 1097 N State St Spc 221, Hemet, CA 92543-1536
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October 15, 2014; Nutek Disposables, Inc. Issues Alert Due to Potential Bacteria in Baby Wipes
- October 15, 2014
FOR IMMEDIATE RELEASE — Oct. 25, 2014 — MCELHATTAN, PA — Nutek Disposables, Inc. of McElhattan, PA has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred's, Kidgets, Member's Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some packages may contain bacteria. These wipes were distributed by Nutek prior to October 21, 2014 to the following retail stores: Walgreens, Sam's Club, Family Dollar, Fred's, and Diapers.com.
After receiving a small number of complaints of odor and discoloration, Nutek conducted microbial testing that showed the presence of a bacteria, calledBurkholderia cepacia (B. cepacia), in some of these products. Soon after, on October 3, 2014 the company initiated a voluntary withdrawal of lots that had tested positive for the bacteria, as well as other baby wipes in the surrounding time frame. After some additional lots were tested, as a precautionary measure, Nutek believed it was a prudent decision to withdraw all its baby wipe products.
B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. If you believe you have a weakened immune system or chronic lung disease and you have used one of the affected wipe products, you should call your doctor promptly for medical advice.
As of October 3, 2014, the date of the original withdrawal, the company had received only one report of irritation. Numerous reports of complaints have since been received by the company that include rash, irritation, infections, fever, gastro-intestinal issues, and respiratory issues, though these reports have not been confirmed to be related to the use of these products.
The company has not identified the cause of the problem, but is continuing to investigate. In the interim, Nutek has stopped shipping baby wipes manufactured at the facility. Nutek takes the safety of consumers and the quality of its products very seriously and is taking all appropriate steps to address the issue and ensure this does not happen again.
The company is working with the U.S. Food & Drug Administration and the affected retailers and distributors throughout this process to address the issue.
Consumers who have purchased this product can return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-855-646-4351, Monday–Friday, 7 am–7 pm CST and Saturday–Sunday, 9 am–5 pm CST.
Brand Name
Retailer
Lot Numbers of Product Manufactured by Nutek
Cuties Internet and various retailers All Lots
Diapers.com Diapers.com All Lots
Femtex Family Dollar All Lots
Fred's Fred's All Lots
Kidgets Family Dollar All Lots
Member's Mark Sam's Club All Lots
Simply Right Sam's Club All Lots
Sunny Smiles Walgreens All Lots
Tender Touch Various retailers All Lots
Well Beginnings* Walgreens Certain Lots±
*These lot numbers represent all lots manufactured by Nutek. There may be other lots that are made by manufacturers other than Nutek and that are not subject to this recall.
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July 15, 2014; Voluntary Nationwide Recall of Tattoo Ink, Tattoo Needles, Tattoo kits by White & Blue Lion, Inc. in the City of Industry, CA due to Microbial contamination
- July 15, 2014
FOR IMMEDIATE RELEASE - July 15, 2014 - White & Blue Lion, Inc. in the City of Industry, CA is recalling all lots of tattoo Inks and tattoo needles due to pathogenic bacterial contamination. Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection. As of an extra precaution, we are also recalling all tubes and ink cups as well. The recall includes all tattoo ink, tattoo needles, tubes, ink cups and kits distributed by White & Blue Lion including the ones specifically listed below:
Tattoo Inks
(sold in kits and separately)
Brand
Code
Size
All Colors
Multi colored Chinese Dragon Image with black and white lettering
Lot No. OR20036
Batch #8
Best if used by 16/12/16
5 ml bottle
Tattoo Needles (included in kits)
Brand
Codes
Lot No
Expiration
Individually packaged in groups of 5
None – labeled as “CE0197 Pre-made tattoo needle”
“sterilized by E.O. Gas”
Art No. 1203RL, 1205M, 1205RL, 1205RS, 1209RL, 1207RL, 1207M, 1207RS, 1209M, 1209RS
201308, 201307, 201312, 201402, 201311, 201310
JUN2018
The inks and needles are sold in tattoo kits and the inks are also sold separately by 8Decades and White & Blue Lion, Inc. through www.amazon.com & www.ebay.com
There was a report of one illness as of today’s date.
FDA Laboratory testing has found microbial bacterial contamination in both the inks and needles.
From the tattoo kits (ink and needles) a variety of potentially pathogenic organisms were isolated and identified including: Gram negative bacteria, Gram positive rods and cocci, which when identified to the genus and species levels included: Bacilllus spp. Sphingomonas paucimobilis, Micrococcus lutes, Corynebacterium spp., Clostridium botulinum and other Clostridium spp. No Mycobacteria were isolated.
From the ink sets a variety of potentially pathogenic organisms were isolated and identified including: Gram negative bacteria, Gram positive rods and cocci, which when identified to the genus and species levels included: Bacillus spp, Acinetobacter spp., Staphylococcus haemolyticus, Sphingomonas paucimobilis. No Mycobacteria were isolated.
This recall is being made with the knowledge of the US Food and Drug Administration.
Consumers with any questions should contact us at 1-626-586-3485 from Monday to Friday between the hours of 9am to 6pm PST.
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April 15, 2014; Natural Organics, Inc. Recalls one lot of THURSDAY PLANTATION TEA TREE MOUTHWASH Due to Bacterial Contamination EXPANDED to Include THURSDAY PLANTATION TEA TREE MOUTHWASH 8.45 fl oz/ 250mL e, Product No. 6710, Lot 10952
- April 15, 2014
FOR IMMEDIATE RELEASE — April 15, 2014 – Natural Organics, Inc. is expanding its April 3, 2014 recall of distributed Thursday Plantation Tea Tree Mouthwash to Lot 10952 after they were notified by its contract manufacturer INTEGRIA Healthcare (Australia) Pty Ltd. that this second lot of Tea Tree Mouthwash failed microbial contamination testing due to potential bacterial contamination.
This bacterial contaminant, Pseudomonas aeruginosa, could pose a health risk to consumers. While a health hazard is unlikely, we have initiated this recall becausePseudomonas can cause serious illness in immune compromised individuals. For more information on Pseudomonas, please visit the Centers for Disease Control and Prevention's Website at http://www.cdc.gov.
The mouthwash was distributed nationwide to retail stores and to the following foreign country: United Kingdom.
The mouthwash is packaged in clear plastic bottles with green and white labeling bearing the following product code and lot number printed on the back panel of the product label: Thursday Plantation, Tea Tree Mouthwash, 8.45 fl oz/ 250ml e, Product No. 6710, Lot 10952
There have been no reported incidents of illness or adverse effects in connection with this product.
No other Nature's Plus products distributed by Natural Organics, Inc. are involved in this recall.
This voluntary expanded recall is announced in accord with FDA guidelines.
Consumers who may have purchased affected Thursday Plantation, Tea Tree Mouthwash are advised to return them to the place of purchase. Consumers with questions may contact the company at 1-800-645-9500 Monday- Friday from 8:30am to 5:30pm (EST).
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February 20, 2014; Sample of Blacker brand liner tattoo ink was positive for contamination with Norcadia spp.
- February 20, 2014
Description: FDA Sample of Blacker brand liner tattoo ink was positive for contamination with Norcadia spp.
Contact: Minko Inc., 4707 95th St N., St Petersburg, FL 33708-3723
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January 16, 2014: The Mentholatum Company Issues Voluntary Nationwide Recall of Rohto Eye Drops Made in Vietnam
- January 16, 2014
FOR IMMEDIATE RELEASE - Orchard Park, NY – January 16, 2014 - The Mentholatum Company announced today it is conducting a voluntary recall to the retail level of Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops Made in Vietnam. This recall includes ONLY lots of product that were manufactured in Vietnam and DOES NOT include eye drops made in Japan. The lot numbers for products made in Vietnam will include the letter "V," for example, "Lot 3E1V," and will be located on the bottom panel of the carton, and on the bottom of the eye drop bottle. Products manufactured in Japan are not included in this recall and continue to be available to consumers.
The Mentholatum Company is initiating the recall due to a manufacturing review at the production facility in Vietnam involving sterility controls. To date, there has been no evidence indicating that product does not meet specifications; however, the company is taking this action as a precautionary measure.
The product is sold nationwide over-the-counter at pharmacies and retail stores. This recall affects Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops that were made in Vietnam only, which can be identified by the words "Made in Vietnam" on the side carton panel under the company name and address information, as well as on the back label of the bottle.
The Mentholatum Company is notifying its distributors and retailers by letter to stop distribution and follow instructions in the recall letter. Consumers that have recalled product should contact the company for instructions.
Questions about this recall may be directed to The Mentholatum Company Customer Service Department at 1-877-636-2677 Monday – Friday 9 AM to 5 PM (EST).
No reports of injury have been associated with the products at issue. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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November 15, 2013; New Reliance Traders, Inc.- Voluntarily Recalls Hashmi Surma Special Eyeliner Due to Elevated Lead Levels
- November 15, 2013
FOR IMMEDIATE RELEASE - November 15, 2013 - New Reliance Traders, Inc announced it is voluntarily recalling all lots of Hashmi Surma Special Eyeliner because it was found to contain high levels of lead that could cause health problems to consumers, particularly infants, small children, and pregnant women. New Reliance Traders is notifying consumers and customers not to use this product. Recent analysis of the product found that the products contained lead levels high as 167387 parts per million (ppm).
The Hasmi Surma Special Eyeliner was distributed to retail stores in CT, PA, MD, and RI.
The Hashmi Surma Special Eyeliner is packed within a 12 GM gold bottle, enclosed within blue packaging with English translation on the front and foreign language character on the back. The product is particularly used as eye make-up.
One complaint has been received to date.
The recall was initiated after it was discovered that product contained high levels of lead based on laboratory testing conducted by The Connecticut Department of Consumer Protection. Consumers who have purchased Hashmi Surma Special eyeliner are urged not to use the product and should return it to New Reliance Traders for a full refund. Consumers with questions may contact our company at 718-894-2927 Monday-Friday 9 am-5pm ET.
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September 23, 2013; W.S. Badger Company Voluntarily Recalls Select Lots of Daily SPF 30 Kids & Baby Sunscreen Lotions Due to Microbial Contamination
- September 23, 2013
W.S. Badger Co. Inc. today announced it is voluntarily recalling all lots of its 4-ounce SPF 30 Baby Sunscreen Lotion and one lot of its 4-ounce SPF 30 Kids Sunscreen Lotion (lot # 3164A) due to microbial contamination. The products were tested and found to be contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi.
No adverse reactions have been reported in connection with these products.
Both sunscreens are sold in the USA & Canada online and at major retailers as well as independent food co-ops and pharmacies. This product can be identified by matching the UPC with the Lot code, which can be found on the top front of the tube crimp.
The affected lots include the following:
SPF 30 Baby Sunscreen Lotion 4oz (UPC: 634084490091&634084490114) Lot #’s 3024A, 3057B, 3063A, 3063B, 3132A, 3133A
SPF 30 Kids Sunscreen Lotion (UPC: 634084490145 & 634084490169) Lot # 3164A
Consumers who have purchased the SPF 30 Baby Sunscreen Lotion should not use these products and may return product to the original point of purchase for a full refund, or contact Badger directly at 1-800-603-6100 or email recalls@badgerbalm.com between the hours of 8:30-4:30 ET, Monday - Friday.
Media: Deirdre Fitzgerald 603-283-5220 deef@badgerbalm.com
Adverse events that may be related to the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
Online: www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid, pre-addresses Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addresses form.
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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September 06, 2013; Altaire Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 9 Lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution Sold Under Several Brands Because the Preservative May Not Be Effective Through Expiry
- September 06, 2013
Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level. There have been no reports of adverse effects to consumers so far. However, due to complaints of mold found in the 30 mL bottles after use, concerns regarding the effectiveness of the preservative after use and handling of the product by consumers have prompted the recall.
A product whose preservative may not be effective could lead to the use of a contaminated product which creates a potential risk for eye infection. It has been confirmed by Altaire that all lots of product were sterile at the time of release, and that the preservative was effective when challenged against the USP Preservative Effectiveness Test. It has also been confirmed by Altaire that its production facility is not the source of any reported contaminants.
The product is known generically as Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution and labeled as follows:
equate Restore Tears Lubricant Eye Drops Carboxymethylcellulose Sodium 0.5%, Sterile, 1 FL OZ (30 mL) - Distributed by Wal-Mart Stores, Inc.;
Lubricant EYE DROPS FOR MILD TO MODERATE DRY EYE, STERILE, 1 FL OZ (30 mL), for Mild to Moderate Dry Eye - Distributed by CVS Pharmacy, Inc.;
lubricant eye drops for mild to moderate dry eye, STERILE, 1 FL OZ (30 mL) - Dist. by Target Corp.
Only the lots listed below are affected, and the recall is limited to the product in the 30 mL size:
Lot # 11440, expiration date 09/2013, labeled for CVS;
Lot # 11441, expiration date 09/2013, labeled for CVS;
Lot # 12042, expiration date 01/2014, labeled for Wal-Mart and CVS;
Lot # 12103, expiration date 02/2015, labeled for Wal-Mart;
Lot # 12203, expiration date 05/2015, labeled for Wal-Mart and CVS;
Lot # 12207, expiration date 05/2015, labeled for Wal-Mart;
Lot # 12293, expiration date 08/2015, labeled for Wal-Mart;
Lot # 12352, expiration date 09/2015, labeled for Target and CVS;
Lot # 12356, expiration date 09/2015, labeled for Target and CVS.
Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution is a non-prescription (OTC) drug product used to relieve dryness of the eye and packaged in a plastic bottle inside a unit box. Lot numbers can be found printed horizontally on the side of the label and on the bottom flap of the box. The lots listed above were distributed between February 2012 and April 2013. The product was sold nationwide at retail stores.
Altaire Pharmaceuticals is initiating the recall as a precautionary measure. Altaire takes its mission of consumer care and providing quality products very seriously. The company has reformulated the product with an enhanced preservative system. All lots of the product in the 30 mL size identified with lot numbers beginning with 13 (i.e. 13000) have been made with the enhanced preservative system.
Altaire Pharmaceuticals is notifying its customers of the recall by phone and letters for further notification to their retail stores. Consumers who have the product with any of the lot numbers listed above should stop use of the product immediately and return it to the place of purchase.
Consumers with questions regarding this recall can contact Altaire Pharmaceuticals at 1-800-258-2471, Monday – Friday from 9 am – 5 pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online: www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available
at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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September 18, 2002 Softsoap Antibacterial Liquid Hand Soap (with hand pump)
- September 18, 2012
PRODUCT
Softsoap Antibacterial Liquid Hand Soap (with hand pump) Rainforest Series (triclosan), 7.5 FL OZ (221 mL) bottles. Recall # D-402-2.
CODE
Rainforest product:
SKU Number
127800 Code dates: 2134,2135,2136
Rainforest product mixed product displays:
SKU Number:
102781 Code Dates: 2158, 2161.
RECALLING FIRM/MANUFACTURER
Colgate-Palmolive Co., Piscataway, NJ, by letters starting on July 2, 2002. Firm initiated recall is ongoing.
REASON
Cross contamination with another soap product (contains undeclared ingredients: aloe vera, fragrance, glycerin, hydrolyzed silk).
VOLUME OF PRODUCT IN COMMERCE
19,293 cases.
DISTRIBUTION
Nationwide.
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November 19, 2009; P&G Voluntarily Recalls Specific Lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom
- November 19, 2009
FOR IMMEDIATE RELEASE - Nov. 19, 2009 - Cincinnati - The Procter & Gamble Company (NYSE:PG) announced today it is voluntarily recalling three lots of its Vicks Sinex nasal spray in three countries: the United States, Germany and the United Kingdom.
The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany.
There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. B. cepacia poses little medical risk to healthy individuals.
P&G detected this problem during routine quality control at the plant and promptly took action. The company
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September 3, 2009; Arbonne International, LLC Announces Voluntary Recall of One Lot of Seasource Detox Spa Foaming Sea Salt Scrub;
- September 03, 2009
FOR IMMEDIATE RELEASE - September 3, 2009 - Irvine, CA - Arbonne International, LLC ("Arbonne") has voluntarily recalled one lot of its Seasource Detox Spa Foaming Sea Salt Scrub. The recalled products were manufactured by a third party and distributed nationwide through Arbonne Independent Consultants. The product comes in a 6.8 fluid oz white tube and is identified with a lot number on the crimping at the top of the tube. The Seasource Detox Spa Foaming Sea Salt Scrub products affected by this voluntary recall are ONLY from the following lot number (with shipping dates ranging from March 28, 2008 to July 15, 2009): Z928
This voluntary recall was initiated by Arbonne as a result of discovering the presence of Pseudomonas aeruginosa bacteria in the recalled lot. No other lots are affected. The organism Pseudomonas aeruginosa may cause dermatitis, soft tissue infections, bacteremia, and a variety of system infections, particularly with users who are immunosuppressed. Because the Foaming Sea Salt Scrub is used to exfoliate the skin
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May 12, 2009; Fun Express, Inc. recalls children
- May 12, 2009
FDA Alerts Consumers to Recall of Water-Based Face Paints
Fun Express, Inc. recalls children
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April 29, 2009; Personal Care Products Conducts Nationwide Recall of Non-Acetone Nail Polish Remover Because of Possible Health Risk
- April 29, 2009
FOR IMMEDIATE RELEASE -- April 29, 2009 -- Personal Care Products of Bingham Farms, MI is voluntarily conducting a nationwide recall of all lots of Personal Care non-acetone nail polish remover, conditioner enriched with gelatin, 6 fl. oz., UPC 4815592076, because it does not meet product specifications and has the potential to cause chemical burns to the fingers of users.
The product has been sold nationwide in small discount retail stores and retailers are being instructed to remove the product from sale and to return it to Personal Care Products.
Personal Care has received two complaints of burns to the fingers resulting from the use of the product.
Any person who purchased a bottle of Personal Care non-acetone nail polish remover, conditioner enriched with gelatin is urged to return it to the store of purchase for a refund. Consumers with questions may contact Personal Care Products at 1-248-258-1555, Monday through Friday from 9 a.m. until 5 p.m. EDT.
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April 08, 2009; Castillo Distributor Inc has announced the voluntary recall all Monell
- April 08, 2009
FOR IMMEDIATE RELEASE --Little Ferry, NJ, April 08, 2009, Castillo Distributor Inc has announced the voluntary recall all the products Monell
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January 5, 2009; Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover
- January 05, 2009
FOR IMMEDIATE RELEASE -- Easton, Maryland
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November 13, 2008; CSI USA, Inc. Issues Voluntary National Recall of Topical Acne Cream
- November 13, 2008
FOR IMMEDIATE RELEASE -- GALLATIN, TN, November 13, 2008
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November 7, 2008; Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments
- November 07, 2008
FOR IMMEDIATE RELEASE -- Fort Washington, PA (November 7, 2008)
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September 8 , 2004 John Frieda brand Sheer Blonde Curvaceous Blonde Curl-Defining Styler
- September 04, 2008
PRODUCT
John Frieda brand Sheer Blonde Curvaceous Blonde Curl-Defining Styler, Curls Swirls Brightens Blond Hair, packaged in 6.7 fl. Oz. plastic bottles with pump sprayer, 6 bottles per case. Item/SKU #7-17226-00502-2; Order No. 0723859. Recall # F-427-4.
CODE
Lots: # S001AW037 and #S001AW040.
RECALLING FIRM/MANUFACTURER
Andrew Jergens Co, Cincinnati, OH, by email, fax, and letter on March 22, 2004. Firm initiated recall is complete.
REASON
The product may be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
104 cases.
DISTRIBUTION
PA.
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August 6, 2008, Mommy
- August 06, 2008
CODE: All products with lot codes/expiration dates 1388/05/2009, 1419/05/2009, and 1478/07/2009
RECALLING FIRM/MANUFACTURER: Recalling Firm: MOM Enterprises, Inc., San Rafael, CA, by telephone and internet on May 28, 2008.
Manufacturer: LifeTech Resources, Chatsworth, CA. Firm initiated recall is ongoing.
REASON: Unapproved New Drug; product contains chlorphenesin and phenoxyethanol
VOLUME OF PRODUCT IN COMMERCE: 5,628 units
DISTRIBUTION: Nationwide
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July 30, 2008, Fraxel Green Tea Infusion Mask and Faxel Deep Hydration Mask by Reliant Technologies Inc., Mountain View, CA,
- July 30, 2008
PRODUCT:
a) Fraxel Green Tea Infusion Mask maintenance, by Fraxel Skin Ecology System, in cardboard box, 3 masks per box Part number 09-03730, Recall # F-503-8;
b) Fraxel Deep Hydration Mask post treatment, by Fraxel Skin Ecology System, in cardboard box, 3 masks per box Part number 09-03772, Recall # F-504-8;
c) Fraxel Deep Hydration Mask post treatment, by Fraxel Skin Ecology System, in cardboard box, 10 masks per box Part number 09-03721, Recall # F-505-8
CODE: All product shipped before 04/09/2008, with an expiration date of September 2009
RECALLING FIRM/MANUFACTURER: Recalling Firm: Reliant Technologies Inc., Mountain View, CA, by telephone and letter beginning May 22, 2008. Manufacturer: Dicon Technologies Llc, Allendale, NJ. Firm initiated recall is ongoing.
REASON:
a) Products may be contaminated with Penicillium spp., and Mucor spp; b) and c) Products may be contaminated with Penicillium spp., Candida sp., and Cladosporium spp.
VOLUME OF PRODUCT IN COMMERCE: 17,428 masks
DISTRIBUTION: Nationwide
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May 2, 2008, FDA Notice: Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health
- May 02, 2008
FOR IMMEDIATE RELEASE -- Elgin, IL -- May 2, 2008 Hydrox Labs, Elgin, IL has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. As a result of this recall, Cardinal Health is initiating a voluntary recall of the same alcohol-free mouthwash. The FDA has been apprised of the action. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash.
Product was distributed to hospitals, medical centers, and long term care facilities nationwide.
B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia. B. cepacia is a known cause of infections in hospitalized patients. B. cepacia bacteria are often resistant to common antibiotics. The effects of B. cepacia on people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with CF.
The recall includes the following products:
Description
Reorder Number
Alcohol-Free Mouthwash, Cardinal Health, 4 oz.
AG-210
Product lot number 26228 is affected. Affected product can be identified by checking the lot code stamped on the Cardinal Health label. The Lot number is located on the side of the bottle.
The mouthwash may also be found in certain Personal Hygiene Hospital Admission Kits. If you received mouthwash labeled for Cardinal Health from your healthcare provider, please check to see if the reorder number on the label matches the recalled reorder numbers listed above, then check to see if the lot number matches the recalled lot number.
Customers who have Cardinal Health labeled alcohol free mouthwash which is being recalled should stop using the product and contact Cardinal Health for instructions.
Cardinal Health is notifying their customers via overnight mail and is arranging for all product to be returned for credit.
-
April 23 , 2008 L
- April 23, 2008
PRODUCT
L
-
April 16, 2008, ACT Restoring Anticavity Fluoride Mouthwash (sodium fluoride 0.05%), Cool Splash Spearmint flavor,
- April 16, 2008
PRODUCT
ACT Restoring Anticavity Fluoride Mouthwash (sodium fluoride 0.05%), Cool Splash Spearmint flavor, 18 fl oz. Recall # D-184-2008
CODE
Lot: RTP0078G, exp. 01/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Chattem Inc., Chattanooga, TN, by e-mail on March 17, 2008.
Manufacturer: Access Business Group Llc, Ada, MI. Firm initiated recall is ongoing.
REASON
Some bottles are mislabeled as mint flavor instead of spearmint flavor and do not declare the presence of color ingredients green 3 and yellow 10.
VOLUME OF PRODUCT IN COMMERCE
26,976 units
DISTRIBUTION
Nationwide
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February 8, 2008; Chattem Issues URGENT Voluntary Nationwide Recall of Icy Hot Heat Therapy Products
- February 08, 2008
Chattem, Inc. announced today that it is initiating a voluntary Nationwide recall of its Icy Hot Heat Therapy products, including consumer "samples" that were included on a limited promotional basis in cartons of its 3 oz. Aspercreme
-
January 29, 2008; Nationwide Recall of NuCel Labs Eye Drops and Eye/Ear Wash Products
- January 29, 2008
NuCel Labs of Idaho Falls, Idaho announced today that it is conducting a voluntary nationwide recall of all Eye Drops and Eye/Ear Wash. This recall follows an FDA inspection in which product testing indicated that there was bacteria and particulate matter in the product deeming these products non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness.
Products are packaged in 1/4 oz plastic bottles. Eye drops are labeled: Eye Drops Caution: Do Not Use With Implants. Wash is labeled Eye/Ear Wash. All products labeled "Eye Drops Caution: Do Not Use With Implants" or "Eye/Ear Wash" are subject to the recall action. There are no lot numbers or expiration dates on the product. Approximately 500 units of these products have been distributed nationwide through retail outlets and the internet.
No illnesses or injuries have been reported to date.
The company has ceased the production and distribution of the product. Consumers who may have any of these products on hand are advised not to use them. Consumers are asked to return them to NuCel Lab, 1380 Curtis Ave, Idaho Falls, Idaho 83402 or discard them and send NuCel Lab a purchase receipt for a full refund. Consumers with questions may call NuCel Lab at 208-542-0325.
Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
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January 18, 2008; LOreal Initiates Nationwide Recall of LOreal Paris Dream Blonde Bleach and Lightening Care Kit Due to Misprinted Directions
- January 18, 2008
LOreal Paris, a division of LOreal USA, has initiated a voluntary recall from retail stores in the United States for the LOreal Paris Dream Blonde (Babys Breath Blonde #100 Ultra Lightening) Bleach and Lightening care kit. The product was sold in retail outlets in the US from January 1 through January 18, 2008. L'Or
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December 12, 2007, Ketoconazole Shampoo, 2%
- December 12, 2007
PRODUCT
Ketoconazole Shampoo, 2%, Rx only, 4 fl. oz., For topical application only, NDC 0781-7090-04, ANDA 76-942, Recall # D-062-2008
CODE
Lot: 2472.
RECALLING FIRM/MANUFACTURER
Tolmar, Inc., Fort Collins, CO, by telephone and letter on November 9, 2007. Firm initiated recall is ongoing.
REASON
Stability testing indicates product will be out of specification by 12 month time point (Subpotent)
VOLUME OF PRODUCT IN COMMERCE
9,348 units
DISTRIBUTION
PA
-
October 31, 2007, Dentakleen Cavity Fighting Fluoride Toothpaste, Dentakleen Fluoride Toothpaste, Fresh Mint Flavor, Dentakleen Fluoride Toothpaste, Cool Winterfresh Taste, Denta-Kleen Junior Fluoride Toothpaste, Blueberry Flavor, 50 g tubes
- October 31, 2007
PRODUCT
a) Dentakleen Cavity Fighting Fluoride Toothpaste, Great Regular Flavor, 6.4 oz tubes with free toothbrush, labeled ingredients include Sodium Monofluorophosphate 0.7%. Made in China, Recall # D-022-2008;
b) Dentakleen Fluoride Toothpaste, Fresh Mint Flavor, 6.4 oz tubes with free toothbrush, labeled ingredients include Sodium Monofluorophosphate 0.7%. Made in China, Recall # D-023-2008;
c) Dentakleen Fluoride Toothpaste, Cool Winterfresh Taste, 6.4 oz tubes with free toothbrush, labeled ingredients include Sodium Monofluorophosphate 0.7%. Made in China, Recall # D-024-2008;
d) Denta-Kleen Junior Fluoride Toothpaste, Blueberry Flavor, 50 g tubes with bonus toothbrush, labeled ingredients include Monofluorophosphate 500 ppm. Made in China, Recall # D-025-2008;
e) Denta-Kleen Junior Fluoride Toothpaste, Strawberry Flavor, 50 g tubes with bonus toothbrush, labeled ingredients include Monofluorophosphate 500 ppm. Made in China, Recall # D-026-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: One Two For You, Inc., Toa Baja, PR, by visit on June 12, 2007.
Manufacturer: Goldcredit International Enterprises, Wuxi, Jiangsu, China (Mainland). Firm initiated recall is complete.
REASON
Toothpaste from China containing the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
18,720 units
DISTRIBUTION
PR
-
October 31, 2007, Betco Winning Hands Ultra Mild Antibacterial Skin Cleanser
- October 31, 2007
PRODUCT
Betco Winning Hands Ultra Mild Antibacterial Skin Cleanser, Triclosan 0.30%, NET CONTENTS 30.4 fl. oz. (900 mL) bag in box, 37.2 fl. oz. (1100 mL) bag in box, 67.7 fl. oz. (2000 mL) bag in box, 1 Gallon (3.78L) bottles, Recall # D-008-2007
CODE
1 Gallon Bottle (4-1 Gallon Containers per case) Lots 1088639, 1089891, 1087387 --- 900 mL BAG IN BOX (12-900 mL per case) Lot 1088201 --- 1100 mL BAG IN BOX (10-1100 mL per case) Lot 1088201 --- 2000 mL BAG IN BOX (4 - 2000 ml per case) Lot 1090335
RECALLING FIRM/MANUFACTURER
Betco Corp., Ltd, Toledo, OH, by letters on August 24, 2007. Firm initiated recall is ongoing.
REASON
Microbial contamination of Non Sterile Product; the product is contaminated with Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE
1,212 gallons
DISTRIBUTION
Nationwide
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September 26, 2007, DentFresh Fluoride Toothpaste, Mint Flavor, 9 oz tubes
- September 26, 2007
PRODUCT
DentFresh Fluoride Toothpaste, Mint Flavor, 9 oz tubes, labeled ingredients include Sodium Monofluorophosphate and Glycerin. Made in China. Recall # D-974-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dent Fresh USA, Inc., Miami, FL, by press release on July 13, 2007 and letter on July 17, 2007.
Manufacturer: Suzhou City Jinmaco Daily Chemicals Co. Firm initiated recall is ongoing.
REASON
Toothpaste from China may contain the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
126,000 tubes
DISTRIBUTION
FL and Haiti
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September 26, 2007, Fluoride Toothpaste, AmerFresh and Pacific labels, packaged in white opaque or clear plastic tubes
- September 26, 2007
PRODUCT
Fluoride Toothpaste, AmerFresh and Pacific labels, packaged in white opaque or clear plastic tubes, labeled ingredients include odium monofluorophosphate. Sold in three varieties: white paste, clear gel and red gel; container sizes: 0.6 oz, 0.85 oz, 1.5 oz, 2.75 oz, 3 oz and 3 grams. Sold separately or in hygiene kits. Made in China. Recall # D-973-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Phoenix Trading, Inc., Woodinville, WA, by letters on July 10, 2007. Firm initiated recall is ongoing.
REASON
Toothpaste from China contains the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
1,257,701 tubes various sizes; 262,493 kits with toothpaste
DISTRIBUTION
Nationwide
-
September 26, 2007, DentaPro Cavity Fighting Fluoride Toothpaste, Spearmint flavor,and BrightMax Fluoride Toothpaste
- September 26, 2007
PRODUCT
a) DentaPro Cavity Fighting Fluoride Toothpaste, Spearmint flavor, 6.4 oz tubes, labeled ingredients include Sodium monofluorophosphate 0.8% and Diglycol. Made in China, Item #9112, Recall # D-975-2007;
b) BrightMax Fluoride Toothpaste, 6.4 oz tubes. Made in China. Item #9111, Recall # D-976-2007;
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Donnamax Inc., Brooklyn, NY, by press release on August 7, 2007 and by letters on/about August 21, 2007.
Manufacturer: Goldcredit International Enterprises, Wuxi, Jiangsu, China (Mainland). Firm initiated recall is ongoing.
REASON
Toothpaste from China contains the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
185 cases
DISTRIBUTION
NY, PA, MA, MI, OH, IL, MS, SC, GA, FL, ID
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September 26, 2007, Attends Personal Cleansing Washcloths, Large
- September 26, 2007
PRODUCT
Attends Personal Cleansing Washcloths" Large; Adult Wet Washcloths packaged 70 washcloths per low profile tub (Catalog #22574) and Refill Pack (Catalog #22573), Recall # F-522-7
CODE
Lot numbers: 06300 0220715, 06301 0220715, 06302 0220715, 06303 0220715, 06304 0220715, 06305 0220715, 06306 0220715, 06307 0220715
RECALLING FIRM/MANUFACTURER
Rockline Industries, Springdale, AK, by e-mail, telephone and letter beginning on May 1, 2007. Firm initiated recall is ongoing.
REASON
Adult wipes used for perineal cleaning have an off-odor and are discolored.
VOLUME OF PRODUCT IN COMMERCE
14,642 cases
DISTRIBUTION
NC and CA
-
September 26, 2007, Gilchrist & Soames toothpaste/dentifrice, 0.65 fl.oz.
- September 26, 2007
PRODUCT
Gilchrist & Soames toothpaste/dentifrice, 0.65 fl.oz., Manufactured in China. Product was distributed to hotels/motels for use by their guests and was distributed both separately and as part of a dental kit with toothpaste, sample kits with toothpaste and a VIP kit with toothpaste, Recall # F-532-7
CODE
All tubes without a lot number embossed into the crimp end.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gilchrist & Soames, Indianapolis, IN, by press release and letter on August 13, 20007.
Manufacturer: Ming Fai Manufactory, Dong Guan, China (Mainland). Firm initiated recall is ongoing.
REASON
Toothpaste contains diethylene glycol.
VOLUME OF PRODUCT IN COMMERCE
658,054 tubes
DISTRIBUTION
Nationwide and Internationally
-
September 12, 2007, Gentle Rain Extra Mild Sensitive Skin Moisturizing Body Wash and Shampoo, 21 fl. oz
- September 12, 2007
PRODUCT
Gentle Rain Extra Mild Sensitive Skin Moisturizing Body Wash and Shampoo, 21 fl. oz. (621 ml), USA Product # 7233, UPC # 11701-041-26, Recall # F-501-7
CODE
1046669
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coloplast Corp. Skin Care Div., Minneapolis, MN, by telephone beginning on August 6, 2007.
Manufacturer: Coloplast Corp. Skin Care Div., North Mankato, MN. Firm initiated recall is ongoing.
REASON
Gentle Rain Extra Mild might be contaminated with bacteria including Kiebsiella oxytoca.
VOLUME OF PRODUCT IN COMMERCE
5,412 units
DISTRIBUTION
AL, AR, CA, GA, IL, KY, MA, MD, ME, MN, NJ, PA, SC, TX, and WI
-
September 5, 2007, Tri-Leaf brand and Select Medical Products brand Spearmint Fluoride Toothpaste
- September 05, 2007
PRODUCT
Spearmint Fluoride Toothpaste, labeled ingredients include Sodium Monofluorophosphate, made in China, sold as individual tubes and in kits under the following labels and sizes: a) Tri-Leaf brand: 17g, 24g, 42g, 78g, 130g; b) Select Medical Products brand: 24g, 43g, 77g, Recall # D-969-2007
CODE
All lots within expiry
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amsino International Inc, Pomona, CA, by telephone on July 12, 2007 and by letters on July 13, 2007.
Manufacturer: Shanghai Whitecat Shareholding Co., Ltd, Shanghai, China (Mainland). Firm initiated recall is ongoing. REASON
Toothpaste from China may contain the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
61,739 cases
DISTRIBUTION
Nationwide and Canada
-
September 5, 2007, Oral Bright Fresh Fluoride Toothpaste and Toothpaste/Toothbrush combo, Fresh Spearmint Flavor
- September 05, 2007
PRODUCT
Oral Bright Fresh Fluoride Toothpaste and Toothpaste/Toothbrush combo, Fresh Spearmint Flavor, Net Wt 6.4 oz, labeled ingredients include Sodium Monofluorophosphate 0.8% and Diglycol, Recall # D-968-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: PR Retail Stores, Inc., Carolina, PR, by fax on June 4, 2007.
Manufacturer: Goldcredit International Enterprises, Wuxi, Jiangsu, China (Mainland). Firm initiated recall is ongoing.
REASON
Toothpaste from China may contain the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
Approximately 115,920 tubes
DISTRIBUTION
PR
-
September 5, 2007, Springfresh Fluoride Toothpaste
- September 05, 2007
PRODUCT
Springfresh Fluoride Toothpaste, labeled ingredients include Sodium monofluorophosphate and Glycerin. Sold in 4 package styles: packet, clear plastic tube, white opague plastic tube and aluminum tubes; container sizes: 0.15 oz, 0.3 oz, 0.6 oz, 0.7 oz, 0.85 oz, 1.5 oz, 2.75 oz, 3 oz, 4.6 oz, 6.4 oz, 7 oz, and 3 gm. Product of China, Recall # D-967-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Amenities, Inc. Woodinville, WA, by fax on June 13, 2007 and June 15, 2007, and by letter on June 18, 2007.
Manufacturer: Suzhou Qing Xin Daily Chemical Co., Ltd, Suzhou, China (Mainland). Firm initiated recall is ongoing.
REASON
Toothpaste from China may contain the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
51,756 cases
DISTRIBUTION
Nationwide
-
August 13, 2007; Gilchrist & Soames Initiates Urgent Worldwide Toothpaste Voluntary Recall
- August 13, 2007
Gilchrist & Soames, an Indianapolis-based provider of toiletry products for the hotel industry, has initiated a worldwide voluntary recall of its Gilchrist & Soames 0.65oz/18ml toothpaste manufactured in China for the company by Ming Fai Enterprises International Co., LTD, after independent tests showed some samples of the toothpaste contained diethylene glycol, or DEG.
The United States Food and Drug Administration ("FDA") is not aware of any U.S. reports of poisonings from toothpaste containing DEG. However, the agency is concerned about potential risks from chronic exposure to DEG and exposure to DEG in certain populations, such as children and individuals with kidney or liver disease. DEG in toothpaste has a low but meaningful risk of toxicity and injury to these populations. Toothpaste is not intended to be swallowed, but FDA is concerned about unintentional swallowing or ingestion of toothpaste containing DEG. This voluntary recall is being conducted in cooperation with the FDA. The Company also has notified the Department for Business, Enterprise and Regulatory Reform in the UK to enable it to notify the European Commission to launch a RAPEX notification in the European Union.
Hotels in the United States, Canada, Mexico, Bermuda, Barbados, Dominican Republic or Turks & Caicos that received the recalled toothpaste from the company
-
August 8, 2007, Dentakleen Fluoride Toothpastes
- August 08, 2007
PRODUCT
a) Dentakleen Fluoride Toothpaste, multiple flavors including Regular, Fresh Mint and Winterfresh, 6.4 oz tubes, labeled ingredients include Sodium Monofluorophosphate 0.7% and Sorbitol, Recall # D-946-2007;
b) Denta-kleen Junior Fluoride Toothpaste, Strawberry and Blueberry flavors, Net Weight 50 g tubes, labeled ingredients include Sodium Monofluorophosphate 500 ppm, Glycerin, and Sorbitol, Recall # D-947-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: PR Retail Stores, Inc., Carolina, PR, by fax on June 4, 2007.
Manufacturer: Goldcredit International Enterprises, Wuxi, Jiangsu, China. Firm initiated recall is ongoing.
REASON
Toothpaste from China may contain the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
Approx. 7,112 units
DISTRIBUTION
PR
-
August 8, 2007, BrightMax Cool Peppermint Flavor Cavity Fighting Fluoride Toothpaste and Toothpaste/Brush combo
- August 08, 2007
PRODUCT
BrightMax Cool Peppermint Flavor Cavity Fighting Fluoride Toothpaste and Toothpaste/Brush combo, 1.76 oz and 6.4 oz tubes, labeled ingredients include Sodium monofluorophosphate 0.8%, Sorbitol and Diglycol, Recall # D-945-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: PR Retail Stores, Inc., Carolina, PR, by fax on June 4, 2007.
Manufacturer: Goldcredit International Enterprises, Wuxi, Jiangsu, China (Mainland). Firm initiated recall is ongoing.
REASON
Toothpaste from China contains the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
Approx 193,616 units
DISTRIBUTION
PR
-
August 8, 2007, DentalPro Fresh Spearmint Flavor Fluoride Toothpaste and Toothpaste with Brush Combo
- August 08, 2007
PRODUCT
DentalPro Fresh Spearmint Flavor Fluoride Toothpaste and Toothpaste with Brush Combo, 6.4 oz. tubes, labeled ingredients include Sodium monofluorophosphate 0.8% and Diglycol, Recall # D-944-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: PR Retail Stores, Inc., Carolina, PR, by fax on June 4, 2007.
Manufacturer: Goldcredit International Enterprises, Wuxi, Jiangsu, China (Mainland). Firm initiated recall is ongoing.
REASON
Toothpaste from China contains the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
40,608 units
DISTRIBUTION
PR
-
August 7, 2007; Donnamax Inc. Issues Nationwide Voluntary Recall of Dentapro and Bright Max Brands of Toothpaste
- August 07, 2007
Donnamax Inc. of Brooklyn, NY, has initiated a voluntary recall of the following brands of toothpaste made in China:
DentaPro brand CAVITY FIGHTING FLUORIDE TOOTHPASTE, FRESH SPEARMINT FLAVOR, NET WT. 6.4 oz. - Item No. 9112, UPC 8 71290
-
July 18, 2007, EverFRESH and McKesson Medi-Pak EverFRESH Fluoride Toothpaste, Mint Flavor
- July 18, 2007
PRODUCT
Fluoride Toothpaste, Sodium Monofluorophosphate, made in China; sold under the following labels:
a) EverFRESH Fluoride Toothpaste, Exclusive; 1 tube per box, 144 boxes per case; in 1.5 oz tubes, item TP00015, UPC 766851000155 and 2.75 oz tubes, item TP00275, UPC 766851002753;
b) McKesson Medi-Pak EverFRESH Fluoride Toothpaste, Mint Flavor, in 0.6 oz tubes, reorder 16-TP6, UPC (01)10612479150642, 144 tubes per case, 5 cases per master carton; 1.5 oz tubes reorder 16-TP15, UPC (01)20612479128914, 1 tube per box, 144 boxes per case; 2.75 oz tubes reorder 16-TP275, UPC (01)20612479128921, 1 tube per box, 144 boxes per case, Recall # D-842-2007
CODE
All lots within 3 year expiry
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cypress Medical Products, Ltd., McHenry, IL, by letters dated June 13, and June 14, 2007
Manufacturer: Suzhou Qingxin Daily Chemical Co, Ltd, Suzhou, China. Firm initiated recall is ongoing.
REASON
The toothpaste, manufactured in China, may contain a poisonous chemical, diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
36,190 cases
DISTRIBUTION
Nationwide
-
July 18, 2007, SaniClenz Antimicrobial Cleanser
- July 18, 2007
PRODUCT
SaniClenz Antimicrobial Cleanser (chlorhexidine gluconate) contains 2% w/w Chlorhexidine gluconate with 2% isopropyl alcohol in a nonalkaline base. Enriched with Aloe Vera and Vitamin E. For External use only, 18 fl. oz or 1 gallon Crosstex International NDC058575-320 Reorder Ref # JSCP, Recall # D-837-2007
CODE
Lot numbers 2320, 2336, 2400, 2461 and 2483
RECALLING FIRM/MANUFACTURER
Inopak, Ltd., Ringwood, NJ, by letter on January 4, 2006. Firm initiated recall is complete.
REASON
Product was mislabeled as
-
July 11, 2007, Dr.Cool, Coolmint and Everfresh Toothpaste
- July 11, 2007
PRODUCT
a) Dr.cool Toothpaste Coolmint , Net Wt 120g, labeled ingredients include Sodium Monoflurophosphate 0.5% and Diglycol. Product of China, Recall # D-832-2007;
b) Coolmint Toothpaste and Superdent Coolmint Toothpaste with toothbrush, Net Wt 120g, labeled ingredients include Sodium Monoflurophosphate 0.5% and Diglycol. Product of China,
Recall # D-833-2007;
c) Everfresh Assortment Toothpaste and Everfresh 1 + 1 Assortment Toothpaste with toothbrush, 25ml, labeled as 'Cavity Fighter', Recall # D-834-2007
CODE
a) Bar Code: 6926597170008;
b) Bar Code: 6926597170015;
c) Bar Code: 6926597089539
RECALLING FIRM/MANUFACTURER
Recalling Firm: MainStar America, LLC, Miami, FL, by letter on June 4, 2007.
Manufacturer: Goldcredit International Enterprises, Wuxi, Jiangsu, China. Firm initiated recall is ongoing.
REASON
Toothpaste from China that contains the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
4,966 units
DISTRIBUTION
FL, PR, and Guatemala
-
July 11, 2007, Crescent brand toothpaste
- July 11, 2007
PRODUCT
Crescent brand toothpaste & Crescent toothpaste with toothbrush, Net Wt 181g, labeled ingredients include Sodium Monofluorophosphate O.7% and Sorbitol, MADE IN CHINA, Recall # D-829-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: H & Y Trading Co., Capitol Heights, MD, by telephone on June 11, 2007.
Manufacturer: Shandong Chiping Foreign Trade Prod, Taiyun, China. Firm initiated recall is ongoing.
REASON
Toothpaste from China may contain the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
300 tubes
DISTRIBUTION
MD and D.C.
-
July 11, 2007, DermaFreeze 365 Neck & Chest and Neck and Chest, Instant Firming Lotion with GABA-Biox Firming Complex
- July 11, 2007
PRODUCT
DermaFreeze365 Neck & Chest (UPC Code 6-05923-36503-0), Neck and Chest, Instant Firming Lotion"with GABA-Biox Firming Complex", Recall # F-434-7
CODE
All product on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Woodridge Labs Inc., Panorama City, CA, by email and letter on March 13, 2007, and by press release on March 23, 2007.
Manufacturer: Cosmetic Technologies, Inc., Newbury Park, CA. Firm initiated recall is ongoing.
REASON
Product is contaminated with Pseudomonas aeruginosa and is not promoted for use in the eye area.
VOLUME OF PRODUCT IN COMMERCE
866,997 pcs
DISTRIBUTION
Nationwide and Canada
-
July 11, 2007, DermaFreeze365 Instant Line Relaxing Formula and Instant Line Relaxing Formula with GABA-Biox
- July 11, 2007
PRODUCT
DermaFreeze365 Instant Line Relaxing Formula (UPC Codes 6-05923-36501-6, 6-05923-36502-3 and 6-05923-10563-6), Instant Line Relaxing Formula"with GABA-Biox", Recall # F-433-7
CODE
All product on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Woodridge Labs Inc., Panorama City, CA, by email and letter on March 13, 2007, and by press release on March 23, 2007.
Manufacturer: Cosmetic Technologies, Inc., Newbury Park, CA. Firm initiated recall is ongoing.
REASON
Product is contaminated with Pseudomonas aeruginosa and is promoted for use in the eye area.
VOLUME OF PRODUCT IN COMMERCE
866,997 pcs
DISTRIBUTION
Nationwide and Canada
-
July 4, 2007, Colgate Sodium Monoflorophosphate Toothpastes
- July 04, 2007
PRODUCT
a) Colgate Toothpaste, Sodium Monoflorophosphate 0.76% 5 oz (100ml) tube, Regular, Recall # D-825-2007;
b) Colgate Toothpaste, Sodium Monoflorophosphate 1.1%, 5 oz (100ml) tube, Herbal, Colgate Herbal, Recall # D-826-2007
c) Colgate Toothpaste, 0.76% Sodium, Monoflorophosphate 0.10% sodium fluoride, 5 oz (100ml) tube Colgate Gel, Recall # D-827- 2007;
d) Colgate Toothpaste, Sodium Monoflorophosphate 0.76% 5 oz (100ml) tube, Triple with Germ Defense, Recall # D-828-2007
CODE
a) Regular 3400 2008 UPC 6 001067 066613;
b) Herbal: MNF 04 2005 OB EXP 04 2008 UPC 6 001067 021452;
c) Gel: 50712A10 UPC 6 001067 066293;
d) All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: MS USA Trading, Inc., North Bergen, NJ, by telephone and visits beginning June 13, 2007.
Manufacturer: Colgate Palmolive (PTY) LTD, Boskburg, South Africa. Firm initiated recall is ongoing.
REASON
Toothpaste may contain Diethylene Glycol
VOLUME OF PRODUCT IN COMMERCE
122 cases (144 tubes per case)
DISTRIBUTION
MD, NJ, NY and PA
-
July 4, 2007, Listerine Agent Cool Blue Plaque-Detecting Rinse, Bubble Blast Flavor
- July 04, 2007
PRODUCT
Listerine Agent Cool Blue Plaque-Detecting Rinse, Bubble Blast Flavor, 250 mL and 500 mL bottles, Recall # D-824-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil PPC, Inc., Morris Plains, NJ, by press release on April 11, 2007 and letters on April 13, 2007.
Manufacturer: McNeil PPC, Inc., Lititz, PA. Firm initiated recall is ongoing.
REASON
Product may be contaminated with gram negative microorganisms.
VOLUME OF PRODUCT IN COMMERCE
9,500,000 bottles
DISTRIBUTION
Nationwide including PR
-
June 20, 2007, Cooldent-Coolmint Toothpastes
- June 20, 2007
PRODUCT
a) Cooldent-Coolmint Ice Toothpaste & Toothpaste/Brush Combo, 6.4 oz tubes, labeled ingredients include Sodium Monofluorophosphate 0.5% and Diglycol. UPC barcodes: 8-40929-03901-5 & 8-40929-03903-9, Recall # D-814-2007;
b) Cooldent-Spearmint Toothpaste & Toothpaste/Brush Combo, 6.4 oz tubes, labeled ingredients include Sodium Monofluorophosphate 0.5% and Diglycol. UPC barcodes: 8-40929-03904-6 & 8-40929-03906-0, Recall # D-815-2007;
c) Cooldent-Fluoride Toothpaste & Toothpaste/Brush Combo, 6.4 oz tubes, labeled ingredients include Sodium Monofluorophosphate 0.5% and Diglycol. UPC barcodes: 8-40929-03907-7 & 8-40929-03908-4, Recall # D-816-2007
CODE
a) Item Numbers: S3901(toothpaste with toothbrush) & S3903 (toothpaste only);
b) Item Numbers: S3904 (toothhpaste only) & S3906 (toothpaste with toothbrush);
c) Item Numbers: S3907 (toothpaste only) & S3908 (toothpaste with toothbrush)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Selective Imports Corp., Vernon, CA, by telephone on May 31, 2007 and by letter on June 4, 2007.
Manufacturer: Goldcredit International Enterprises, Wuxi, Jiangsu, China (Mainland). Firm Initiated recall is ongoing.
REASON
Toothpaste from China contains the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
399,120 tubes
DISTRIBUTION
AZ, CA, FL, GA, IL, UT, & TX
-
June 14, 2007; Counterfeit Colgate Toothpaste Found
- June 14, 2007
The Colgate
-
June 8, 2007; Recall Request of Dental Toothpaste Made in China due to Possible Risks to the Health
- June 08, 2007
Pitusa, National Lumber, Everything To Weight, Supermarkets and Supermarkets Pitusa of Carolina, Puerto Rico, is asking for return to our stores of all dental toothpaste of origin
-
June 8, 2007; Urgent Voluntary Nationwide Recall of Toothpaste
- June 08, 2007
Gold City Enterprise LLC, Hallandale, Florida, is initiating a nationwide recall in accordance with the U.S. Food and Drug Administration (FDA) of the toothpaste made in China involving:
Lot #777A
-
May 31, 2007, Artificial Tears Lubricant Eye Drops,
- May 31, 2007
PRODUCT
Artificial Tears Lubricant Eye Drops,
-
May 25, 2007; AMO Announces Voluntary Recall of Complete Moistureplus Multipurpose Solution
- May 25, 2007
In response to information received today from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections, Advanced Medical Optics is immediately and voluntarily recalling its Complete MoisturePlusTM contact lens solutions. CDC data was made available to AMO today showing that it had completed interviews with 46 patients who had developed Acanthamoeba keratitis (AK) since January 2005. A total of 39 of these patients were soft contact lens wearers, 21 of whom reported using Complete MoisturePlusTM products. The CDC estimates a risk of at least seven times greater for those who used Complete MoisturePLUSTM solution versus those who did not.
While AMO continues to work with the CDC and the U.S. Food and Drug Administration (FDA) to further assess the data, it is acting with an abundance of caution to voluntarily recall Complete MoisturePlusTM from the market. There is no evidence to suggest that today
-
May 16, 2007, New Alpine Xtreme Evergreen Forest Body Wash
- May 16, 2007
PRODUCT
New Alpine Xtreme Evergreen Forest Body Wash, packaged in 28 fl. oz. plastic bottles, 6 bottles per case, Recall # F-259-7
CODE
Lot # 286071
RECALLING FIRM/MANUFACTURER
Vi Jon Laboratories, Inc, Saint Louis, MO, by telephone on April 13, 2007 and by e-mail on April 24, 2007. Firm initiated recall is ongoing.
REASON
The product is contaminated with Enterobacter gergoviae.
VOLUME OF PRODUCT IN COMMERCE
10,242/28 fl. oz. bottles
DISTRIBUTION
Nationwide
-
April 25, 2007, Studio Basics & Bon Image Foam cosmetic applicators and sponges
- April 25, 2007
PRODUCT
Foam cosmetic applicators and sponges, Made in Korea
a) UPC 0-79625-02007-6, Studio Basics professional tools face, 2 rectangle compact sponges, non-latex replacement sponges;
b) UPC 0-79625-02014-4, Studio Basics professional tools face, 2 contouring sponges, non-latex;
c) UPC 0-79625-02015-1, Studio Basics professional tools face, travel sponge multi-pack includes 2 disposable exfoliating sponges, 2 cosmetic cleansing sponge, 7 cosmetic wedges non-latex, 1 round compact sponge, non-latex;
d) UPC 0-79625-02167-7, Studio Basics professional tools, 2 round blending sponges for a smooth streak-free finish;
e) UPC 0-79625-02183-7, Studio Basics professional tools, 6 cosmetic wedges, non-latex;
f) UPC 0-79625-02189-9, Studio Basics professional tools face, 12 round blending sponges for a smooth streak-free finish, non-latex;
g) UPC 0-79625-02190-5, Studio Basics professional tools face, 32 cosmetic wedges, non-latex;
h) UPC 0-79625-02018-2, Studio Basics professional tools face, 4 finger sponges for quick touch-ups, non-latex;
i) UPC 0-79625-02020-5, Studio Basics professional tools face, make-up artist sponge for full make-up coverage, non-latex;
j) UPC 0-79625-02006-9, Studio Basics professional tools, 2 round compact sponges, oil resistant, non-swelling and non-crumbling replacement sponges, non-latex;
k) UPC 0-79625-02016-8, Studio Basics professional tools face, 2 foundation diamonds for blending make-up in contours of face, non-latex sponges;
l) UPC 0-79625-02019-9, Studio Basics professional tools face, oval sponge with carry case, non-latex;
m) UPC 0-79625-01013-8, Mon Image, 2 Round Blending Sponges, 2-1/2' diameter;
n) UPC 0-79625-01175-3, Mon Image, 12 Round Blending Sponges, Non-Latex;
o) UPC 0-79625-01176-0, Mon Image, 32 Blending Sponge Wedges, Non-Latex, Recall Number: F-197-7
CODE
All packages of the following UPC codes: 0-79625-02007-6, 0-79625-02014-4, 0-79625-02015-1, 0-79625-02167-7, 0-79625-02183-7, 0-79625-02189-9, 0-79625-02190-5, 0-79625-02018-2, 0-79625-02020-5, 0-79625-02006-9, 0-79625-02016-8, 0-79625-02019-9, 0-79625-01013-8, 0-79625-01175-3, 0-79625-01176-0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Paris Presents, Inc., Gurnee, IL., by letters dated May 26, 2006 and June 6, 2006.
Manufacturer: S & G Sponge Co., Ltd., Sungnam City, Kyungki-Co, Korea, Republic Of (South). Firm initiated recall is complete.
REASON
The cosmetic sponges contain latex residue, which can lead to severe allergic reactions in persons sensitive to latex.
VOLUME OF PRODUCT IN COMMERCE
1,207,821 packages
DISTRIBUTION
Nationwide and Internationally
-
April 19, 2007; Vi-Jon Issues Voluntary Nationwide Consumer Recall of Alpine Xtreme Evergreen Forest Body Wash
- April 19, 2007
Vi-Jon, Inc. issued a voluntary nationwide consumer product recall of a single lot of 28 fluid ounce bottles of Alpine Xtreme Evergreen Forest Body Wash after determining the presence of a bacteria, Enterobacter gergoviae, in some of the product samples tested. The company became aware of this after determining that some of the product had become cloudy in appearance. An investigation concerning the cause of the issue is ongoing.
After conducting a thorough assessment, the company concluded that the risk of illness in healthy individuals following use of this product is very low. However, there could be an increased health risk of small wound, skin or more serious infections to individuals with cuts, scrapes, rashes or other compromised skin conditions, or weakened or suppressed immune systems. There have been no consumer adverse health events reported that are related to this issue.
The only affected product is Alpine Xtreme Evergreen Forest Body Wash, which is green in color. The Lot Code involved in this recall is 286071; identified by the first six numbers printed on the back of the bottle between the pump and the top of the back label. The recall docs not affect any other Alpine Xtreme Body Wash product. Consumers should discontinue using and properly discard the product, and may obtain a full refund through calling the company's toll-free consumer line, 1-888-593-0593, and mailing in the back label, including the UPC code. Additional information can be found at the product website, www.alpinextreme.net.
Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company
-
April 4, 2007, Baby Wipe Products by Rockline Industries
- April 04, 2007
PRODUCT
a) Baby Basics by Albertson's Pop-Ups; 160 count; UPC #41163 25036 (unscented) and #41163 25035 (scented), Recall # F-137-7;
b) Baby Wipes (Dollar General); 80 and 240 counts; UPC #71287 85966 (80 ct.) and #41163 85967 (240 ct.); distributed by Dolgencorp, Inc. (Dollar General), Recall F-138-7;
c) Food Lion Baby Wipes; 400 count; UPC #35826 06288, Recall # 139-7;
d) Hannaford Pop-Ups Baby Wipes; 80 and 160 counts; UPC #41268 12183 (80 ct. unscented), #41268 12185 (80 ct. scented), #41268 13280 (160 ct. unscented) and #41268 13279 (160 ct. scented), Recall # F-140-7;
e) H-E-B baby; 240 ct.; UPC #41220 16806 (unscented) and #41220 16805 (scented), Recall # F-141-7;
f) American Fare Clean Cloths; 80 ct.; UPC #72000 117140; and Little Ones Premium Wipes, 400 ct., UPC #72000 14537; made for Kmart Corporation, Recall # F-142-7;
g) Kroger Comforts Baby Wipes; 160 and 400 ct.; UPC #11110 36170 (160 ct. unscented), #11110 36169 (160 ct. scented), #41260 33452 (400 ct. unscented) and #41260 33451 (400 ct. scented), Recall # F-143-7;
h) Long's Baby Wipes; 160 Count.; UPC #12333 (unscented) and #41163 25035 (scented), Recall # F-144-7;
i) Meijer Drybabies; 240 and 400 counts; UPC #19283 51472 (240 ct. unscented) and #19283 51474 (400 ct. scented), Recall # F-145-7;
j) Publix Premium Baby Wipes; 80, 160 and 320 counts; UPC #41415 04467 (80 ct. unscented), #41415 05667 (80 ct. scented), #41415 08167 (160 ct. unscented), #41415 08067 (160 ct. scented), #41415 08267 (320 ct. unscented) and #41415 08367 (320 ct. scented), Recall # F-146-7;
k) Pure'nGentle Baby Wipes; 160 ct.; UPC #71287 85646 (unscented) and #71287 85631 (scented); manufactured by Rockline Industries, Recall # F-147-7;
l) Member's Mark Moist Wipes Pop-Ups; 740 count; UPC #81131 90060, Recall # F-148-7;
m) Stater Bros. Baby Wipes; 80 Count; UPC #74175 04955, Recall # F-149-7;
n) Equate Pop-Ups; 80 and 160 counts; UPC #71287 85975 (80 count tub), #71287 85978 (80 count refill); #71287 85641 (160 count bag), Recall # F-150-7;
o) Parent's Choice Premium Baby Wipes; 240 and 400 counts; UPC #71287 85823 (240 count), #71287 858778 (400 count); imported for Wal-Mart Canada Corp., Recall # F-151-7;
p) Wegman's Baby Wipes; 80 and 240 counts; UPC #77890 63623 (80 count unscented), #77890 31414 (240 count scented), Recall # F-152-7;
q) Western Family CozyCare; 160 count; UPC #15400 07263, Recall # F-153-7;
r) Teddy;s Choice Soft Touch Quilted Baby Wipes; 240 count; UPC #60383 74456 (unscented) and #60383 74457 (scented), Recall # F-154-7;
s) Option+ Supreme Baby Wipes; 80 count; UPC #71290 00226, Recall # F-155-7;
t) Simply Kids Baby Wipes; 160 count; UPC #82795 00030 (unscented) and #82795 00029, Recall # F-156-7;
u) Safeway Pop-Ups; 80, 160 and 400 counts; UPC #58200 79259 (80 ct. unscented), #58200 79240 (160 ct. scented) and #58200 79224 (400 ct. unscented), Recall # F-157-7
CODE All codes from 06233 to 06253 (Julian dates corresponding to product produced Aug 21, 2006 to Sept. 10, 2006).
RECALLING FIRM/MANUFACTURER
Rockline Industries, Springdale, AR, by press release, telephone and letters on November 17, 2006. Firm initiated recall is ongoing.
REASON
The product may be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
194,924 units
DISTRIBUTION
Nationwide and Canada
-
March 28, 2007, Ultra Brite Advanced Whitening All in One Clean Mint Toothpaste in a 6.0 oz tube
- March 28, 2007
PRODUCT
Ultra Brite Advanced Whitening All in One Clean Mint Toothpaste in a 6.0 oz tube, over-the-counter, Distributed by Colgate-Palmolive Company, New York, NY NDC # 065954-064-60; SKU 0156685, UPC 3500056685, Recall # D-468-2007
CODE
Lots 6293, 6294, 6295, 6296, 6297, 6301, 6302, 6303, 6304 and 6305. All lots expire between 10/08 and 01/09.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Colgate Palmolive Company, Jeffersonville, IN, by letter on January 12, 2007.
Manufacturer: Colgate Palmolive Company, Mission Hills, Mexico. Firm initiated recall is ongoing.
REASON
Misbranded; The label ingredient statement is incorrect. The product contains the following ingredients which are not declared: sodium fluoride, PEG-12 and cocamidopropyl betaine and does not contain the following ingredients which are declared: sodium monophosphate, alumina and glycerin.
VOLUME OF PRODUCT IN COMMERCE
1,441,200 tubes
DISTRIBUTION
Nationwide
-
March 6, 2007; Bausch & Lomb Initiates Limited Voluntary Recall of Twelve Lots of ReNu MultiPlus Solutions Due to Potential for Shortened Shelf Life
- March 06, 2007
Bausch & Lomb (NYSE/BOL) has initiated a limited voluntary recall from distribution centers and retail shelves in the United States and specific other countries of 12 lots of ReNu MultiPlus lens care solution made at its plant in Greenville, SC because they contain an elevated level of trace iron. This may result in discoloration of the solution in some bottles, and the shelf life of the product may be shortened to less than its two-year expiration date, due to a potential loss of effectiveness over time. The Company has received no reports of serious adverse events associated with these lots and believes virtually all of the affected product, manufactured about a year ago, has already been used by consumers. Bausch & Lomb has notified the U.S. Food and Drug Administration of this voluntary action.
About a million bottles of solution from nine of the 12 lots were originally distributed in the United States. Product from the 12 affected lots was also distributed in Canada, Latin America, Korea and Taiwan, where it is also being recalled.
The company initiated an investigation after receiving three customer reports of discolored solution. The root cause of the discoloration was determined to be an elevated level of trace iron in a single batch of raw material sourced from an outside supplier. Iron is an element present at trace levels
-
February 27, 2007, Skin Effects by Dr. Jeffrey Dover Products
- February 27, 2007
PRODUCT
a) Skin Effects Daily Anti-Aging Cream with SPF 15,(Octinoxate 7.5%, Oxybenzone 5%), Net Wt. 2 oz (56g) jars, UPC 0-50428-07901-0, Recall # D-425-2007;
b) Skin Effects by Dr. Jeffrey Dover Advanced Brightening Complex, (Hydroquinone) 2%, Net wt. 1oz (28.4g), UPC 0-50428-07899-0; Recall # D-426-2007;
c) Skin Effects by Dr. Jeffrey Dover Complete Lip Care System (Avobenzone 2% and Octinoxate 7.5%), System includes; Lip Smoothing Scrub Net wt. .49 oz. (14g), Peptide Treatment Serum Net wt. .08 oz. (2.4g) and Lip Balm SPF 15 Net wt. .08 oz. (2.3g), UPC 0-500428-08677-3, Recall # D-427-2007;
d) Skin Effects by Dr. Jeffrey Dover Lightweight Moisturizing Souffle with SPF 30+, Avobenzone 3%, Octinoxate 7.5%, and Octisalate 5%), Net wt. 1 oz. (29g) jars, UPC 0-50428-09340-5, Recall # D-428-2007;
e) Skin Effects by Dr. Jeffrey Dover Redness Control Daily UV Moisturizer SPF 30+, (Octinoxate 7%, Oxybenzone 6% and Octisalate 5%), Net wt. 1 oz. (29g) jars, UPC 0-50428-09341-2; Recall # D-429-2007;
f) Skin Effects by Dr. Jeffrey Dover Lightweight Moisturizing Souffle SPF 30+ for Sensitive Skin, (Avobenzone 3%, Octinoxate 7.5%, and Octisalate 5%), Net wt. 1 oz. (29g) jars, UPC 0-50428-09339-9, Recall # D-430-2007
CODE
a) Lot Number/EXP Date: FT5 EXP. 0507 F25 EXP 0507 F35 EXP 0607
GG5 EXP0507 GZ5 EXP0607 GY5 EXP0607 HL5 EXP 0607 A05 EXP0607
KD5 EXP0607 BG6 EXP0208 BI6 EXP0208 ED6 EXP0408 EZ6 EXP0408
HY6 EXP0408 JY6 EXP0708;
b) Lot Numbers/EXP Date: FT5 EXP 0607 FX5 EXP 0607 GS5 EXP 0607
GV5 EXP0607 HE5 EXP 0607 LA5 EXP 1107 LE5 EXP 1107 LB5 EXP 1107
LC5 EXP 1107 LF5 EXP1107;
c) Lot Numbers/Exp Date: LOT BG6 EXP 0108 LOT BJ6 EXP 0108 LOT BM6 EXP 0108;
d) Lot Numbers: FG6 EXP 0408 GL6 EXP 0408 J56 EXP1008;
e) Lot Numbers: 6E1 EXP 0508 42734-0 EXP 1008;
f) Lot Numbers; FI6 EXP 0408 GM6 EXP 0408 J66 EXP 1008
RECALLING FIRM/MANUFACTURER
Diversified Distribution, Woonsocket, RI, by telephone on November 7, 2006. Firm initiated recall is ongoing.
REASON
Labeling; Outer carton fails to include lot number and expiration.
VOLUME OF PRODUCT IN COMMERCE
129,298 units
DISTRIBUTION
Nationwide
-
February 14, 2007, Systane free Lubricant Eye Drops Liquid Gel
- February 14, 2007
PRODUCT
Systane
-
January 24, 2007 Lubriderm Moisture Mitts, Skin Moisturizing Lotion-2007
- January 24, 2007
PRODUCT
Lubriderm Moisture Mitts, skin moisturizing lotion:
a) Lubriderm Moisture Mitts 15 ct. - Case UPC: 50052800489405; Lubriderm Mitt Unit UPC: 052800489400 Promotional Display -Lubriderm Moisture Mitts 15 ct 12 pc PDQ: Case UPC: 00052800928343; Lubriderm Mitt Unit UPC: 0528009489400;
b) Lubriderm Moisture Mitts 15 ct 12 pc PDQ: Case UPC: 00052800929388, Luriderm Mitt Unit UPC: 05200489400 Promotional Display -Lubriderm MX 16 oz w/Lubriderm Mitt 15 ct & IRC x18PDQ display containing: 6 boxes of 15 single use mitts 4 bottles of Lubriderm Nourishing Lotion 16 oz., 4 bottles Lubriderm Advanced Therapy Moisturing Lotion 16 oz., 4 bottles Lubriderm Skin Nourishing Moisturizing Lotion with Sea Kelp 16 oz: Case UPC 00052800927810, Lubriderm Mitt Unit UPC: 052800489400;
c) Promotional Display - Lubriderm MX 19.6 oz. & Lubriderm Mitts 15 ct x 24 PDQ Display containing: 6 boxes of 15 single use mitts, 6 bottles Lubriderm Advanced Therapy Moisturizing Lotion 19.6 oz., 6 bottles Lubriderm Daily Moisturizing Lotion 19.6 oz., 6 bottles of Lubriderm Skin Moisturizing Lotion with Sea Kelp 19.6 oz. Case UPC 00052800927902, Lubriderm mitt Unit UPC 052800489400;
d) Lubriderm Moisture MItts UPC 052800489400, each case contains boxes of 12 mitts, Recall # F-093-7
CODE
a) Case Lot #'s: 00286SD2, 00386SD1, 00386SD2, 00986SD1, 00986SD1A, 01086SD1, 01086SD2, 01186SD1, 01486SD1, 01586SD1, 01686SD1, 0168SD1, 0186SD1;
b) Case lot #'s: 00196SD1, 03086SD1, 03086SD2, 03186SD1, 03186SD2;
c) Case lot #''s 00896SD1, 01196SD1, 01296SD1, 01296SD2, 01396SD1, 01396SD2, 01496SD1, 01496SD2, 01596SD1, 01596SD2, 02196SD1;
d) Lot #'s: 171602, 172602, 173602, 174602, 174601, 175601, 175603, 177603, 177604, 177605, 178605, 181605, 182605, 183605, 186605, 187605, 188605, 189605, 191606,192606, 193606, 194606, 195606, 196606, 198606, 199606, 200606, 200607, 201607, 202607, 203607, 205607, 206607, 207607, 208608, 209608, 210608, 212608, 213608, 215608, 216608, 219608, 220609, 212609, 222609, 227609, 230609, 233609
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer, Inc., Morris Plains, NJ, by mailing notification packages on October 11, 2006.
Manufacturer: Pacon Manufacturing Corp., Somerset, NJ. Firm initiated recall is ongoing.
REASON
Lubriderm Moisture Mitts were tested and found to contain mold - Aspergillus fumigatus, Aspergillus versicolor, and Penicillium sp.
VOLUME OF PRODUCT IN COMMERCE
24,069 cases of 12 mitts each (288,828 mitts)
DISTRIBUTION
Nationwide
-
January 24, 2007, Lubriderm Moisture Mitts, skin moisturizing lotion
- January 24, 2007
PRODUCT
Lubriderm Moisture Mitts, skin moisturizing lotion: a) Lubriderm Moisture Mitts 15 ct. - Case UPC: 50052800489405; Lubriderm Mitt Unit UPC: 052800489400 Promotional Display -Lubriderm Moisture Mitts 15 ct 12 pc PDQ: Case UPC: 00052800928343; Lubriderm Mitt Unit UPC: 0528009489400;
b) Lubriderm Moisture Mitts 15 ct 12 pc PDQ: Case UPC: 00052800929388, Luriderm Mitt Unit UPC: 05200489400 Promotional Display -Lubriderm MX 16 oz w/Lubriderm Mitt 15 ct & IRC x18PDQ display containing: 6 boxes of 15 single use mitts 4 bottles of Lubriderm Nourishing Lotion 16 oz., 4 bottles Lubriderm Advanced Therapy Moisturing Lotion 16 oz., 4 bottles Lubriderm Skin Nourishing Moisturing Lotion with Sea Kelp 16 oz: Case UPC 00052800927810, Lubriderm Mitt Unit UPC: 052800489400;
c) Promotional Display - Lubriderm MX 19.6 oz. & Lubriderm Mitts 15 ct x 24 PDQ Display containing: 6 boxes of 15 single use mitts, 6 bottles Lubriderm Advanced Therapy Moisturing Lotion 19.6 oz., 6 bottles Lubriderm Daily Moisturing Lotion 19.6 oz., 6 bottles of Lubriderm Skin Moisturing Lotion with Sea Kelp 19.6 oz. Case UPC 00052800927902, Lubriderm mitt Unit UPC 052800489400;
d) Lubriderm Moisture MItts UPC 052800489400, each case contains boxes of 12 mitts,
Recall # F-093-7
CODE
a) Case Lot #'s: 00286SD2, 00386SD1, 00386SD2, 00986SD1, 00986SD1A, 01086SD1, 01086SD2, 01186SD1, 01486SD1, 01586SD1, 01686SD1, 0168SD1, 0186SD1;
b) Case lot #'s: 00196SD1, 03086SD1, 03086SD2, 03186SD1, 03186SD2;
c) Case lot #''s 00896SD1, 01196SD1, 01296SD1, 01296SD2, 01396SD1, 01396SD2, 01496SD1, 01496SD2, 01596SD1, 01596SD2, 02196SD1;
d) Lot #'s: 171602, 172602, 173602, 174602, 174601, 175601, 175603, 177603, 177604, 177605, 178605, 181605, 182605, 183605, 186605, 187605, 188605, 189605, 191606,192606, 193606, 194606, 195606, 196606, 198606, 199606, 200606, 200607, 201607, 202607, 203607, 205607, 206607, 207607, 208608, 209608, 210608, 212608, 213608, 215608, 216608, 219608, 220609, 212609, 222609, 227609, 230609, 233609
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer, Inc., Morris Plains, NJ, by mailing notification packages on October 11, 2006.
Manufacturer: Pacon Manufacturing Corp., Somerset, NJ. Firm initiated recall is ongoing.
REASON
Lubriderm Moisture Mitts were tested and found to contain mold - Aspergillus fumigatus, Aspergillus versicolor, and Penicillium sp.
VOLUME OF PRODUCT IN COMMERCE
24,069 cases of 12 mitts each (288,828 mitts)
DISTRIBUTION
Nationwide
-
January 3, 2007 Anastasia Diabetic Skin Care Therapy Hand & Body Treatment-2007
- January 03, 2007
PRODUCT
Anastasia Diabetic Skin Care Therapy Hand & Body Treatment, 4 oz. jar, Recall # F-083-7
CODE
Lot #2000D6
RECALLING FIRM/MANUFACTURER
Recalling Firm: Anastasia Marie Laboratories, Inc., Oklahoma City OK., by telephone and letter beginning October 13, 2006.
Manufacturer: American Pharmaceuticals & Cosmetics, Inc., Fort Worth, TX. Firm initiated recall is ongoing.
REASON
Hand & Body Cream is contaminated with Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE
1,481- 4oz. jars
DISTRIBUTION
Nationwide
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January 3, 2007, Anastasia Diabetic Skin Care Therapy Hand & Body Treatment
- January 03, 2007
PRODUCT
Anastasia Diabetic Skin Care Therapy Hand & Body Treatment, 4 oz. jar, Recall # F-083-7
CODE
Lot #2000D6
RECALLING FIRM/MANUFACTURER
Recalling Firm: Anastasia Marie Laboratories, Inc., Oklahoma City OK., by telephone and letter beginning October 13, 2006.
Manufacturer: American Pharmaceuticals & Cosmetics, Inc., Fort Worth, TX. Firm initiated recall is ongoing.
REASON
Hand & Body Cream is contaminated with Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE
1,481- 4oz. jars
DISTRIBUTION
Nationwide
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November 21, 2006; Advanced Medical Optics Announces Voluntary Recall of 18 Lots of Complete(R) MoisturePLUS(TM) Contact Lens Care Products Distributed and Sold in the U.S.
- November 21, 2006
Advanced Medical Optics, Inc., a global ophthalmic surgical and eye care products company, today announced a nationwide, voluntary recall of certain lots of its 12-ounce COMPLETE MoisturePLUS(TM) multipurpose contact lens care solution and Active Packs. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at its manufacturing plant in China, AMO is recalling 18 lots distributed in the U.S. that were manufactured on the same production lines during the same production period. Non-sterility of a contact lens solution may have serious health consequences, including eye infection and microbial keratitis. AMO has not received any reports of adverse health events associated with the recalled product lots in the U.S.
Lot numbers are located on the top of the product box and on the side of the product bottle. The recalled product lots include:
Package Lot No. Product Description Bottled Lot Number(s) in Kit
ZB03087 COMPLETE MoisturePLUS Active Pack ZB03085, ZB02845
ZB03724 COMPLETE MoisturePLUS Active Pack ZB03713, ZB03506
ZB03734 COMPLETE MoisturePLUS Active Pack ZB03713, ZB03506
ZB03735 COMPLETE MoisturePLUS Active Pack ZB03713, ZB03510
ZB03736 COMPLETE MoisturePLUS Active Pack ZB03713, ZB03510
ZB03739 COMPLETE MoisturePLUS Active Pack ZB03737, ZB03510
ZB02710 COMPLETE MoisturePLUS 12oz (360 mL) ZB02709
ZB02714 COMPLETE MoisturePLUS 12oz (360 mL) ZB02713
ZB02718 COMPLETE MoisturePLUS 12oz (360 mL) ZB02717
ZB02722 COMPLETE MoisturePLUS 12oz (360 mL) ZB02721
ZB02746 COMPLTE MoisturePLUS 2 X 12 oz ZB02745
ZB02750 COMPLETE MoisturePLUS 2 X 12 oz ZB02749
ZB02771 COMPLETE MoisturePLUS 2 X 12 oz ZB02770
ZB02792 COMPLETE MoisturePLUS 2 X 12 oz ZB02791
ZB02796 COMPLETE MoisturePLUS 2 X 12 oz ZB02795
ZB02800 COMPLETE MoisturePLUS 2 X 12 oz ZB02799
ZB02804 COMPLETE MoisturePLUS 2 X 12 oz ZB02803
ZB03535 COMPLETE MoisturePLUS 2 X 12 oz ZB03534
Contact lens users who experience symptoms of an eye infection such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling, should remove their lenses and consult their eye care provider immediately.
Consumers who believe they are in possession of the recalled product should discontinue use immediately and call 1-877-884-7779 Monday through Friday between 8 a.m. and 5 p.m. Eastern Time or visit www.amo-inc.com for instructions. The company is currently contacting retailers, customers and distributors regarding return and replacement instructions. Reply cards and mailing slips are being provided for return of product. Retailers may also call 1-877-884-7779 Monday through Friday from 8 a.m. through 5 p.m. Eastern Time for more information.
Please report any adverse reactions experienced with the use of this product and/or quality problems to AMO by calling 1-calling 1-800-347-5005 and to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.
Product from the recalled lots was distributed nationwide to food, drug and mass merchandiser accounts. The recall does not include 4-ounce and 16-ounce bottles, or professional samples and packs provided to eye care practitioners.
The U.S. recall includes approximately 183,000 units, representing less than one percent of COMPLETE
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November 17, 2006; Rockline Announces Voluntary Product Withdrawal of Wet Wipes Products
- November 17, 2006
Rockline Industries announced that it has initiated a voluntary nationwide product withdrawal to the retail level of certain lots of its store brand wet wipes. The voluntary withdrawal is a result of routine product testing that detected the presence of a micro-organism known as Burkholderia cepacia (B. cepacia).
According to the Centers for Disease Control (CDC), B. cepacia is a bacteria that can be found in soil and water. The CDC says "B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia. B. cepacia is a known cause of infections in hospitalized patients." Further information on B. cepacia can be found on the CDC website at: (http://www.cdc.gov/ncidod/dhqp/id_BcepaciaFS.html).
"The well being of those who use our products is our top priority," said Alan Perlman, Rockline spokesman. "We are voluntarily removing this product from stores to maintain the highest possible standards of quality for our retail customers and their consumers. While the probability of a health risk is remote, we want to take every precaution. Consumers will receive a full refund or replacement."
There have been no reports of illness related to this incident, according to Perlman. Only a small portion of the company
-
November 15, 2006, Palmer's Baby Butter Massage Lotion
- November 15, 2006
PRODUCT
Palmer's Baby Butter Massage Lotion, Item #4046 and #4046RQ. Each 400 ml (13.5 fl. oz.) HDPE bottle with a pump dispenser is labeled Palmer's Cocoa Butter formula with Vitamin E. Gently Moisturizes Baby's Sensitive Skin. Moisturize, soften and soothe baby's delicate skin with this unique blend of pure Cocoa Butter, Vitamin E and rich emollients. Ingredients: Water, Isopropyl Palmitate, Dimethicone, Glycerine, Theobroma Cacao Seed Butter, Stearic Acid, Propylene Glycol, Bentonite, Lanolin Alcohol, Glyceryl Stearate, PEG 100 Strearate, Tocopheryl Acetae, Aloe Barbadensis Leaf Powder, Cetearyl Alcohol, Diazolidinyl Urea, Fragrance, Methylparaben, Benzyl Alcohol. Coumarin, Propylparaben, Recall # F-056-7
CODE
Lots: L5362A, L5362B, and L5363A
RECALLING FIRM/MANUFACTURER
Recalling Firm: E T Browne Drug Co. Inc., Englewood Cliffs, NJ, by letters and email on September 15, 2006 and September 18, 2006.
Manufacturer: Hayward Laboratories, Inc., East Stroudsburg, PA. Firm initiated recall is ongoing.
REASON
Product is contaminated with Enterobacter gergoviae.
VOLUME OF PRODUCT IN COMMERCE
26,052 bottles
DISTRIBUTION
Nationwide and Internationally
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July 31, 2006; The Mentholatum Company Issues a Nationwide Voluntary Recall of WellPatch Cough & Cold Soothing Vapor Pads in the U.S.
- July 31, 2006
The Mentholatum Company announced today it is conducting a nationwide voluntary recall of WellPatch Cough & Cold Soothing Vapor Pads due to potential serious adverse health effects that could result if the product is ingested by a child removing the patch and chewing on it.
Consumers who have WellPatch Cough & Cold Soothing Vapor Pads should stop using them immediately. The Mentholatum Company is taking this precautionary action to ensure the safety of the consumers who use this product. To date, there have been no serious adverse events reported.
The Mentholatum Company is initiating the recall due to the possibility of adverse events associated with use of the product. WellPatch Cough & Cold Soothing Vapor Pads contain camphor, eucalyptus oil, and menthol. Possible adverse events associated with chewing or ingesting products containing camphor or eucalyptus oils can vary from minor symptoms, such as burning sensation in the mouth, headache, nausea and vomiting, to more severe reactions, such as seizures.
The recall is being conducted with the knowledge of the FDA. WellPatch Cough & Cold Soothing Vapor Pads are labeled for use by children two (2) years of age and older. The directions on the label indicate the patch is to be applied to the throat or chest to allow the vapors to reach the nose and mouth. Once applied, the patch would be within close reach for a child to remove and place in his/her mouth. The Vapor Pad is a topical cough product applied externally and not intended for oral consumption.
The product is sold nationwide over-the-counter at pharmacies and retail stores. This recall affects only the Cough & Cold Soothing Vapor Pads. Consumers should immediately discontinue use of this product and return it to their point of purchase for a full refund or discard it. Consumers requiring more information about this recall can contact The Mentholatum Company Customer Service Department at 1-877-636-2677 or visit www.wellpatch.com.
Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500, by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].
SafetyShare Email this pagePrint this pageChange Font Size Home> Safety> Recalls, Market Withdrawals, & Safety Alerts> Archive for Recalls, Market Withdrawals & Safety AlertsSection Contents MenuRecalls, Market Withdrawals, & Safety Alerts Archive for Recalls, Market Withdrawals & Safety Alerts 2005 -
Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
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May 10, 2006, John Frieda brand brilliant brunette, Starlit Waves, Wave Enhancing Spray packaged in a 6 fl. oz (177 ml) pump spray bottle
- May 10, 2006
PRODUCT
John Frieda brand brilliant brunette, Starlit Waves, Wave Enhancing Spray packaged in a 6 fl. oz (177 ml) pump spray bottle. The product is packed and distributed a 6 x 6 fl. oz bottles per case. The cases are labeled as brilliant brunette, 10947-00, Starlit Waves Wave Enhancing Spray, and contains a UPC code of: 1 07 17226 0947 5. The case labeling also reads: JOHN FRIEDA PROFESSIONAL HAIR CARE. Recall # F-160-6
CODE
Lot #''s T314BM27, T315BM27, T316BM29, T317BM29, T317BM30, T318BM30, T004BM53, T005BM53, T006BM53, T007BM53, T008BM52, T008BM49, T009BM49, V022BM63, V023BM63, V024BM42 & V025BM43
RECALLING FIRM/MANUFACTURER
Recalling Firm: KAO Brands Company, Cincinnati, OH, by letter on February 23 and 24, 2006.
Manufacturer: Les Emballages Knowlton Inc., Canada. Firm initiated recall is ongoing.
REASON
Hair Spray is contaminated with Pseudomonas.
VOLUME OF PRODUCT IN COMMERCE
17,232 cases [103,392 bottles]
DISTRIBUTION
Nationwide
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May 10, 2006, NOW XyliWhite Mouthwash; an all natural, fluoride-free oral rinse; 16 fl. oz. plastic bottles with a foil seal
- May 10, 2006
PRODUCT
NOW XyliWhite Mouthwash; an all natural, fluoride-free oral rinse; 16 fl. oz. plastic bottles with a foil seal, 9 bottles and 20 bottles per carton, UPC 33739-08095, Recall # F-152-6
CODE
Lot numbers 735906 and 736424
RECALLING FIRM/MANUFACTURER
NOW Foods, division of The Fruitful Yield, Inc., Bloomingdale, IL by letter dated March 10, 2006. Firm initiated recall is ongoing.
REASON
A breakdown in the product's preservative system allowed the growth of Enterobacter gergoviae bacteria in the mouthwash
VOLUME OF PRODUCT IN COMMERCE
1,266 bottles
DISTRIBUTION
Nationwide
-
March 29, 2006, Medline Alcohol-Free Mouthwash
- March 29, 2006
PRODUCT
Medline Alcohol-Free Mouthwash, Reorder numbers: MDS095029 for 2-oz. size and MDS095030 for 4-oz. size. Manufacturer's Code is RA05CRR, UPC Code for 2-oz. product is 0 8019616684 1, UPC Code for 4-oz. product is 0 8019674536 7, Recall # F-092-6
CODE
All products with lot codes beginning with the numbers 0503 through 0508 followed by 3 or 4 additional digits.
RECALLING FIRM/MANUFACTURER
Carrington Laboratories, Inc., Irving, TX, by fax on August 23, 2005 and by letter on August 25, 2005, firm initiated recall is ongoing.
REASON
Alcohol-free mouthwash is contaminated with Burkholderia cepacia and is associated with an illness outbreak.
VOLUME OF PRODUCT IN COMMERCE
21,504-2 oz. bottles and 129,000 4-oz. bottles
DISTRIBUTION
Nationwide
-
February 22, 2006, CompleteBath, ReadyBath, and No Rinse Shampoo CapShampoo caps with conditioner
- February 22, 2006
PRODUCT
a) Shampoo caps with conditioner, 1 disposable shampoo cap per package, 30 packages per case.The shampoo caps are manufactured under the
following labels:
(1) CompleteBath,
(2) ReadyBath, and
(3) No Rinse Shampoo Cap,
Recall # F-068-6;
b) No-Rinse Shampoo Cap, Shampoo & Condition Hair with Absolutely No Water, No Mess, No Rinsing. Recall # F-069-6
CODE
All inventory manufactured prior to 10/27/05. An example of the code would be A102705 or B102705.
RECALLING FIRM/MANUFACTURER
ICP Medical, Olivette, MO, by letter dated October 26, 2005 and November 2, 2005, and by press release on October 31, 2005. Firm initiated recall is ongoing.
REASON
Shampoo caps may be contaminated with Serratia marcescens.
VOLUME OF PRODUCT IN COMMERCE
Approximately 10,962/30-cap cases
DISTRIBUTION
IL, OH, and MO
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January 25, 2006 DDF Doctor's Dermatologic Formula, Organic-2006
- January 25, 2006
PRODUCT
a) DDF Doctor's Dermatologic Formula, Organic Sun Protection SPF 30 --- for Sensitive Skin --- Super Antioxidant Complex, Oil & Fragrance-Free --- Meets EU Standards for UVA --- net wt. 4 oz. 113.4 g --- Active ingredients: Titanium Dioxide 2.5% --- Zinc Oxide 4%, UPC 0 60748 00040 3, Recall # D-129-6;
b) DDF Doctor's Dermatologic Formula, Moisturizing Photo-Age Protection SPF 30, Delays Skin Aging, Restores Moisture --- Super Antioxidant Complex, Meets EU Standards For UVA, net. wt. 4 oz. 113.4 g, Active ingredients: Avobenzone 1%, Octinoxate 7.5%, Octisalate 5%, Octocryene 6%, UPC 0 60748 00039 7, Recall # D-130-6;
c) DDF Doctor's Dermatologic Formula, Matte Finish, Photo-Age, Protection SPF 30 --- Minimizes Shine, Super Antioxidant Complex, Oil and Fragance-Free, Meets EU Standards for UVA, net wt. 4 oz. 113.4 g, Active ingredients: --- Avobenzone 1% --- Octinoxate 7.5% --- Octisalate 5% --- Octocrylene 6%, UPC 0 60748 00038 0, Recall # D-131-6;
d) DDF Doctor's Dermatologic Formula, Protective Eye Cream SPF 15 --- 0.5 fl. oz. 15 ml --- Active ingredient: Octinoxate 5% --- Octisalate 1% ---
Zinc Oxide 2%, Recall # D-132-6;
e) DDF Doctor's Dermatologic Formula, Fade Gel 4 --- Hydroquinone 2% --- Proven Lightener, Evens Skin Tone --- Fades Age Spots --- 0.5 fl. oz. 15 ml --- Active Ingredient: Hydroquinone 2%, UPC bar code 0 60748 00032 8, Recall # D-133-6;
f) DDF Doctor's Dermatologic Formula, Fade Cream, SPF 30 --- Hydroquinone 2%, Minimizes Age Spots, Prevents Recurrence, Enriched Moisturizer, net wt. 1.7 oz. 48 g -- Active Ingredients: Avobenzone 1% --- Hydroquinone 2% --- Octinoxate 7.5% --- Octisalate 4% --- Octocrylene 5% --- Oxybenzone 1.5%, UPC 0 60748 00030 4, Recall # D-134-6;
g) DDF Doctor's Dermatologic Formula, Glossy Lip Therapy, SPF 15 --- Plumps --- Protects --- Moisturizes, net wt. 0.25 oz. 7 g --- Active Ingredients: Octinoxate 5% --- Octisalate 3% --- titanium Dioxide 1%, UPC bar code 0 60748 00041 0, Recall # D-135-6
CODE
All lots & sizes on the market
RECALLING FIRM/MANUFACTURER
Recalling Firm: HDS Cosmetics, Inc., Yonkers, NY, by telephone on November 11, 2005 and by letters on November 30, 2005.
Manufacturer: HDS Cosmetics, Inc., Harrison, NY. Firm initiated recall is ongoing.
REASON
Firm does not have adequate stability data to support 2 year expiry period for the OTC products.
VOLUME OF PRODUCT IN COMMERCE
Approx. 218,189 units
DISTRIBUTION
Nationwide
-
January 25, 2006, DDF Doctor's Dermatologic Formulas for Sun Protection SPF 30
- January 25, 2006
PRODUCT
a) DDF Doctor's Dermatologic Formula, Organic Sun Protection SPF 30 --- for Sensitive Skin --- Super Antioxidant Complex, Oil & Fragrance-Free --- Meets EU Standards for UVA --- net wt. 4 oz. 113.4 g --- Active ingredients: Titanium Dioxide 2.5% --- Zinc Oxide 4%, UPC 0 60748 00040 3, Recall # D-129-6;
b) DDF Doctor's Dermatologic Formula, Moisturizing Photo-Age Protection SPF 30, Delays Skin Aging, Restores Moisture --- Super Antioxidant Complex, Meets EU Standards For UVA, net. wt. 4 oz. 113.4 g, Active ingredients: Avobenzone 1%, Octinoxate 7.5%, Octisalate 5%, Octocryene 6%, UPC 0 60748 00039 7, Recall # D-130-6;
c) DDF Doctor's Dermatologic Formula, Matte Finish, Photo-Age, Protection SPF 30 --- Minimizes Shine, Super Antioxidant Complex, Oil and Fragance-Free, Meets EU Standards for UVA, net wt. 4 oz. 113.4 g, Active ingredients: --- Avobenzone 1% --- Octinoxate 7.5% --- Octisalate 5% --- Octocrylene 6%, UPC 0 60748 00038 0, Recall # D-131-6;
d) DDF Doctor's Dermatologic Formula, Protective Eye Cream SPF 15 --- 0.5 fl. oz. 15 ml --- Active ingredient: Octinoxate 5% --- Octisalate 1% --- Zinc Oxide 2%, Recall # D-132-6;
e) DDF Doctor's Dermatologic Formula, Fade Gel 4 --- Hydroquinone 2% --- Proven Lightener, Evens Skin Tone --- Fades Age Spots --- 0.5 fl. oz. 15 ml --- Active Ingredient: Hydroquinone 2%, UPC bar code 0 60748 00032 8, Recall # D-133-6;
f) DDF Doctor's Dermatologic Formula, Fade Cream, SPF 30 --- Hydroquinone 2%, Minimizes Age Spots, Prevents Recurrence, Enriched Moisturizer, net wt. 1.7 oz. 48 g -- Active Ingredients: Avobenzone 1% --- Hydroquinone 2% --- Octinoxate 7.5% --- Octisalate 4% --- Octocrylene 5% ---
Oxybenzone 1.5%, UPC 0 60748 00030 4, Recall # D-134-6;
g) DDF Doctor's Dermatologic Formula, Glossy Lip Therapy, SPF 15 --- Plumps --- Protects --- Moisturizes, net wt. 0.25 oz. 7 g --- Active Ingredients: Octinoxate 5% --- Octisalate 3% --- titanium Dioxide 1%, UPC bar code 0 60748 00041 0, Recall # D-135-6
CODE
All lots & sizes on the market
RECALLING FIRM/MANUFACTURER
Recalling Firm: HDS Cosmetics, Inc., Yonkers, NY, by telephone on November 11, 2005 and by letters on November 30, 2005.
Manufacturer: HDS Cosmetics, Inc., Harrison, NY. Firm initiated recall is ongoing.
REASON
Firm does not have adequate stability data to support 2 year expiry period for the OTC products.
VOLUME OF PRODUCT IN COMMERCE
Approx. 218,189 units
DISTRIBUTION
Nationwide
-
December 28, 2005 Deluxe Dish Detergent Antibacterial Hand Soap
- December 28, 2005
PRODUCT
Deluxe Dish Detergent Antibacterial Hand Soap, 50 oz. Recall # D-067-6
CODE
Lot numbers: (Manufacturing Dates): Tues-Oct. 11, 2005: 284525AA3, 284525AA4, 284525AA5, 284525AA6; Wed. Oct. 12, 2005: 285525AA1, 285525AA3, 28525AA4; Fri. Feb. 25, 2005: 056530AA1, 056530AA2, 056530AA3, 056530AA4, 056530AA5; Mon. Feb. 26, 2005: 059530AA1, 059530AA2, 059530AA3, 059530AA4, 059530AA5, 059530AA6: Tues. Feb. 27, 2005: 060530AA1, 060530AA2, 060530AA3, 060530AA4, 060530AA6, 060530AA8, 060530AA9 and Wed. Feb. 28, 2005: 061530AA8, 061530AA9
RECALLING FIRM/MANUFACTURER
Showline, Raleigh, NC, by letter on/about November 28, 2005. Firm initiated recall is ongoing.
REASON
Misbranded: Lack of active ingredient, Triclosan
VOLUME OF PRODUCT IN COMMERCE
13,068 cases
DISTRIBUTION
Nationwide
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October 26, 2005 Medication Mardel biospheres Maracide for Ick, Velvet, and other external
- October 26, 2005
PRODUCT
a) Medication Mardel biospheres Maracide for Ick, Velvet, and other external Parasites, Contents 2 fl. oz. (59mL) and Fish Care Guide. Virbac Animal Health. Active Ingredients: Malachite green, Chitosan, Recall # V-001-6;
b) Medication Mardel Maroxy for True fungal infections of fish and eggs. Contents 2 fl. oz. (59mL) and Fish Care Guide. Virbac Animal Health. Active Ingredients: Stabilized chlorine oxides, Recall # V-002-6
CODE
a) Lot number: WE433;
b) Lot number: PF422
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc., Fort Worth, TX, by telephone and letters on September 14, 2005. Firm initiated recall is ongoing.
REASON
Product designed to treat external parasites in fish aquariums was packaged with labeling for another product. VOLUME OF PRODUCT IN COMMERCE
19,366 units
DISTRIBUTION
Nationwide and Canada
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October 5 , 2005 Cran brand Face Paint, 5 colors
- October 05, 2005
PRODUCT
Cran brand Face Paint, 5 colors; UPC 7-08820-45951-9, Made in Taiwan, Recall # F-671-5 CODE
All units
RECALLING FIRM/MANUFACTURER
Wholesale Merchandisers, Inc., Grand Rapids, MI, by posting a notice in the stores and on the website, on June 17, 2005. Firm initiated recall is complete.
REASON
Face paints contain unapproved colors and may have been manufactured under conditions whereby they were contaminated with pathogens. VOLUME OF PRODUCT IN COMMERCE
38 packages
DISTRIBUTION
OH
-
October 5, 2005, Baby Wipe Alcohol-Free Baby Wipes and Triad
- October 05, 2005
PRODUCT
a) "Baby Wipe" brands come in either scented or unscented
packaged in a flexible plastic container. Labeled in part: Alcohol-Free Baby Wipes are soft, thick, convenient wipes moistened with a gentle cleansing solution that will clean any part of baby's delicate skin. Sizes: Triad 80 -7.25" x 8, AmeriNet Choice 40
-
May 25 , 2005 Design a Face Make-up
- May 25, 2005
PRODUCT
Design a Face Make-up. Various configurations that include: Theme Packs; Color Compacts, 6 Color Paint Packs; Body Glitter Gel, Glow in the Dark Paint, Face Paint Stencil, Face Paint Foam Stampers, and Face Paints with Book. Recall # F-384-5.
CODE
Item Numbers: (No lots identified) 8900 --Theme Pack - Sports; 8901--Theme Pack - Puppies; 8902--Theme Pack - Kittens; 8903-- Theme Pack - Tiger; 8904--Theme Pack - Clown; 8905 -- Color Compact - White -Clamshell; 8906-- Color Compact - Black -Clamshell; 8907-- Color Compact - Sky Blue -Clamshell; 8908 --Color Compact - Red -Clamshell; 8909 --Color Compact - Green --Clamshell; 8910 --Color Compact - Pink --Clamshell; 8911 --Color Compact - Yellow - Clamshell; 8912 --Color Compact - Orange - Clamshell; 8913 --Color Compact - Brown - Clamshell; 8914 --Color Compact - Purple - Clamshell; 8915 --Color Compact - Navy Blue - Clamshell; 8916 --6 Colors Paint Pack; 8919 --Face Paint Studio - Med. Box; 8920 --Body Glitter Gel; 8921 -- Glow in the Dark Paint; 8922 -- Face Paint Stencil; 8923 --Face Paint Foam Stampers; 8927--Face Paints with Book.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rose Art Industries, Inc., Livingston, NJ, by letter on March 18, 2005.
Manufacturer: Galisa Cosmetics International Corp., Hsintien Taipei Hsien, Taiwan. Firm initiated recall is ongoing.
REASON
Face paint products have caused minor adverse reactions in children. Adverse reactions include redness of the skin or a skin rash, irritation, itching or minor swelling in the area where the paints were applied.
VOLUME OF PRODUCT IN COMMERCE
1,629,444 units.
DISTRIBUTION
Nationwide
-
March 23, 2005 Premier True Color Pigments in 0.5 oz containers
- March 23, 2005
PRODUCT
Premier True Color Pigments in 0.5oz containers including the following shades: Areola Highlighter; Light Pink Areola; Pink Areola; Dark Pink Areola; Light Natural Areola; Natural Areola; Dark Natural Areola; Light Brown Areola; Brown Areola; Dark Brown Areola; Light Ebony Areola; Ebony Areola; Dark Ebony Areola; Sheer Bronze; Bliss; Cherry Cheek; Half Naked; Peach Glow; Dark Taupe Shadow; Taupe Mist; Taupe Halo; Taupe Smudge; Antique Pink; Cherry Red; Spiced Cider; Hot Fuchsia; Blush; Hot Coral; Peaches and Cr
-
March 23, 2005 Starbrite brand Black Magic Color Tattoo Ink
- March 23, 2005
PRODUCT
Tattoo Ink: Starbrite brand Black Magic Color, packaged in individual 1
-
March 23, 2005 Medline Baby Lotion
- February 23, 2005
PRODUCT
a) Medline Baby Lotion, packaged in 2 fl. oz. bottles, 96/case (reorder MSC095007) and 4 fl. oz. bottles, 60/case (reorder MSC095018); Made in U.S.A.; the bottles were sold separately or as components of custom admission kits or complete delivery systems (CDS) containing an admission kit. Recall # F-218-5.
b) Medline Hand & Body Lotion, packaged in 2 fl. oz. bottles, 96.case (reorder MSC095001) and 4 fl. oz. bottles, 60/case (reorder MSC095004) bottles;
Made in U.S.A.; the bottles were sold separately or as components of custom admission kits or complete delivery systems (CDS) containing an admission kit. Recall # F-219-5;
c) Soothe & Cool Cleansing Bath Oil, packaged in 3.5 fl. oz. bottles, 96/case (reorder MSC090472) and 1 gallon bottles, 4/case (reorder MSC090474);
Made in U.S.A.; the bottles were sold separately or as components of custom admission kits. Recall # F-220.5;
d) Medline Baby Oil, packaged in 2 fl. oz. bottles, 96/case (reorder MSC095050), 4 fl. oz. bottles 60/case (reorder MSC095052), 8 fl. oz. bottles, 36/case (reorder MSC095054) and 16 fl. oz. bottles, 12/case (reorder MSC095056 and MSC095056H); Made in U.S.A.; the bottles were sold separately or as
components of custom admission kits or complete delivery systems (CDS) containing an admission kit. Recall # F-221-5.
CODE
a) All bottle lots beginning with a "3" or 4001, 4002, 4003, 4004, 4005, 4006, 4007, 4008, or have no lot number. The following kit reorder numbers contain
2 oz. bottles of baby lotion: DYK1001437A1, DYK1001831D, DYK1004191B, DYK1004272A, DYK1005268A1, DYK1005268A2, DYK1005268A3, DYK1005389B, DYK1005489B1, DYK1005577B1, DYK1005969B, DYK1006010B, DYK1008593B, DYK1008830B1, DYK1008928B, DYK1009313N, DYK1012728B1, DYK1015727M, DYK1016104N1, DYK1016104N2, DYK1017141M, DYK1017509C1, DYK1017509C2, DYK1018533B1, DYK1020236B, DYK1022190P, DYK1022483O1, DYK1066524A, DYK1067380B, DYK1084936B2, DYK1084936B3, DYK1092442N1, DYK1098495B,
DYK1178464B, DYK1178464B1, DYK1186108B, DYKD1000863N, DYKD1001089P, DYKD1002116P, DYKD1002212BB, DYKD1002402A, DYKD1002P, DYKD1002PD, DYKD1003938N, DYKD1004438P, DYKD1005268A, DYKD1005268A1, DYKD1005417B, DYKD1005457B,
DYKD1005457B1, DYKD1005478B2, DYKD1005489B, DYKD1005500P, DYKD1005532P, DYKD1005577B, DYKD1005679B, DYKD1005852A, DYKD1005941B, DYKD1005972B, DYKD1005972B1, DYKD1005972P, DYKD1006085B, DYKD1006230B, DYKD1006230M, DYKD1006230M1, DYKD1006272B, DYKD1006789N, DYKD1006854M, DYKD1006881A, DYKD1006948B, DYKD1006948I, DYKD1007059B, DYKD1007223A, DYKD1007223A1, DYKD1008186M, DYKD1008663A, DYKD1008786B, DYKD1008829P, DYKD1009018P, DYKD1009313N2, DYKD1011059P, DYKD1011867B, DYKD1011867B1, DYKD1011888B, DYKD1011944BC, DYKD1012359I, DYKD1012359I1, DYKD1012359P, DYKD1012380I, DYKD1012612B, DYKD1012728B, DYKD1012918B, DYKD1015787NB, DYKD1015787P, DYKD1015811M, DYKD1016104N, DYKD1016839B, DYKD1017074N, DYKD1017074N1, DYKD1017074P, DYKD1017407T, DYKD1017518MB, DYKD1017518P, DYKD1017582B, DYKD1018497P, DYKD1018505N, DYKD1018505P3, DYKD1018505P4, DYKD1018525B, DYKD1018533B, DYKD1018660P, DYKD1019082B2, DYKD1019365B, DYKD1019365B1, DYKD1019412A, DYKD1019412A1, DYKD1019412P, DYKD1019478B,
DYKD1019478B1, DYKD1019580B, DYKD1019580B1, DYKD1019783B, DYKD1019890P, DYKD1019922B1, DYKD1019933B, DYKD1021834N1, DYKD1021850M, DYKD1021850M1, DYKD1022368B, DYKD1022400P, DYKD1022483O, DYKD1023231P1, DYKD1023471M, DYKD1023513N, DYKD1023674B, DYKD1023682N, DYKD1023682N1, DYKD1023682N2, DYKD1023797OB, DYKD1023807S, DYKD1025011C, DYKD1034163N, DYKD1039911P, DYKD1041379B2, DYKD1041605B1, DYKD1041605B2, DYKD1046316P, DYKD1055671N, DYKD1055671N1, DYKD1055671NN, DYKD1064917I, DYKD1065221BC, DYKD1066577N, DYKD1066599B, DYKD1066599B1, DYKD1067383B, DYKD1067387N, DYKD1067387P, DYKD1071777A, DYKD1084936B1, DYKD1087914A, DYKD1088651B, DYKD1161683B, DYKD1166040N, DYKD11685B1, DYKD13681M, DYKD14142B, DYKD15084A, DYKD151491B1, DYKD151747B2, DYKD151989B, DYKD152262IC1, DYKD152262IC2, DYKD152262TT3, DYKD15262B, DYKD15278ICCU, DYKD15355P1, DYKD15968B, DYKD16051B, DYKD19605P, DYKD22234N, DYKD35385P, DYKD4238M, DYKD44742BC, DYKD48003M, DYKD492446P, DYKD50064C, DYKD55258B1, DYKD5918IC, DYKD704050BX1, DYKD714050B, DYKD821435OB,
DYKDBABYBOY, DYKDBABYGIRL, DYKDN1008523B, DYKDN1085549N, DYKDN1092442N, DYKN1006838N, DYKN1006838N1, DYKN1008593B, DYKN1012165N, DYKN1012307B, DYKN1015466N, DYKN1084936B, DYKN1084936B1, DYKN1153020B
The following kit reorder numbers contain 4 oz. bottles of baby lotion: DYK1002998A, DYK1008440A, DYK1008440A1, DYK1012713M, DYK1017369L2, DYK1017369L3, DYK1018505M, DYK1023735N5, DYK1066649N, DYK1066649N1,DYK1079670A1, DYKD1002734A, DYKD1003120A, DYKD1007024M, DYKD1007031A, DYKD1008488B, DYKD1008881A, DYKD1008958N, DYKD1008958N1, DYKD1011404A, DYKD1011865B,
DYKD1017369L1, DYKD1017369LD, DYKD1018179P,DYKD1018505I, DYKD1018505P2, DYKD1018514N, DYKD1018542N, DYKD1018542N1, DYKD1019290A, DYKD1019927B, DYKD1020287P, DYKD1020376P, DYKD1021345B1, DYKD1022BW, DYKD1023735N1, DYKD1023735N2, DYKD1023735N3, DYKD1023735N4, DYKD1023797M1, DYKD1029707M, DYKD1041489A, DYKD1074113N, DYKD1157463A, DYKD15278P,
DYKD19116N, DYKD29012A, DYKD31019B, DYKD60197B, DYKD63072B, DYKN1007031A, DYKN1012025L, DYKN1069704N, DYKN1079670A, MSC095018HH;
b) All bottle lots beginning with a "3" or 4001, 4002, 4003, 4004, 4005, 4006, 4007, 4008, or have no lot number. The following kit reorder numbers contain 2 oz. bottles of lotion: DYK1000867P, DYK1001299A, DYK1001875A, DYK1001908A, DYK1002261A, DYK1002590M, DYK1002961A1, DYK1002985A, DYK1002985M, DYK1003157A1, DYK1003157A2, DYK1003157A3, DYK1004133A3, DYK1004147A1, DYK1004191A, DYK1004214A, DYK1004385H, DYK1004385K, DYK1004427A, DYK1004980A3, DYK1004980A4, DYK1005385A3, DYK1005386A3, DYK1005386A4, DYK1005386P2, DYK1005395A, DYK1005395A1, DYK1005679A, DYK1005959AM, DYK1005961A1, DYK1006209A, DYK1006272A1, DYK1008104A, DYK1008179A, DYK1008179B, DYK1008179B1,DYK1008414A1, DYK1008523A1, DYK1008617A, DYK1009304A1, DYK1009305A1, DYK1009319A3, DYK1009319A4, DYK1009319A5, DYK1010766M1, DYK1010872A3, DYK1011669A1, DYK1011734A1, DYK1011927A, DYK1012070B1, DYK1012094A, DYK1012094A1, DYK1012713A1, DYK1013004A, DYK1013004A1, DYK1013004A2, DYK1013004A3, DYK1013004A4, DYK1013207A1, DYK1013207A2,DYK1013208A1, DYK1013540A, DYK1013540A1, DYK1014053A, DYK1014167A, DYK1015831I1, DYK1016700A1, DYK1017001A1, DYK1017001A2, DYK1017001A3, DYK1017141M, DYK1017177A1,
DYK1017369L2, DYK1017369L3, DYK1017369S, DYK1017479A4, DYK1017484A, DYK1017549A3, DYK1017718A, DYK1018143A, DYK1018179A,
DYK1018179A1, DYK1018563A, DYK1018645A, DYK1019116A, DYK1019116X, DYK1021280V, DYK1021323Y1, DYK1021338P, DYK1022117N2,
DYK1022400A, DYK1022594A, DYK1022594A1, DYK1022941M5, DYK1023776A1, DYK1024854A, DYK1034111A1, DYK1040238A, DYK1045359M1, DYK1046608A, DYK1059826A2, DYK1059995A, DYK1059995A1, DYK1066514A5, DYK1066515A, DYK1066550A, DYK1066563A, DYK1066649A, DYK1067383A, DYK1067383A1, DYK1067387P, DYK1067410P, DYK1067700M7, DYK1067700M8, DYK1069880A, DYK1082407A1, DYK1088535A, DYK1088658A, DYK1092717A, DYK1101090A1, DYK1101090A2, DYK1165070A, DYK1165686K1, DYK1174835A, DYK1175962A, DYK1176964A, DYK1176964A1, DYK1185811A, DYK1188783A, DYK1191170A1, DYK1194889A, DYK1207466A, DYK50126A2, DYKD1000849AM, DYKD1000909A, DYKD1000957A, DYKD1001038H, DYKD1001134A, DYKD1001183A, DYKD1001191A, DYKD1001457A, DYKD1001457M, DYKD1001457M1, DYKD1001615A, DYKD1001847T, DYKD1001906A, DYKD1002, DYKD1002133A, DYKD1002133A1, DYKD1002140A,
DYKD1002141A, DYKD1002150A, DYKD1002165A, DYKD1002172A1, DYKD1002257A, DYKD1002259A, DYKD1002295A, DYKD10022A, DYKD1002355A, DYKD1002401A, DYKD1002437A, DYKD1002463A, DYKD1002656A, DYKD1002656A1, DYKD1002705A, DYKD1002705A1, DYKD1002718A, DYKD10028M1, DYKD1003157A, DYKD1004133A, DYKD1004133A2, DYKD1004147A, DYKD1004158A, DYKD1004190S,
DYKD1004239A, DYKD1004280M, DYKD1004509P, DYKD1004633M, DYKD1004633M1, DYKD1005216A, DYKD1005384A, DYKD1005386A1, DYKD1005386A2, DYKD1005386P1, DYKD1005388H, DYKD1005400A, DYKD1005419A, DYKD1005419A1, DYKD1005431A, DYKD1005435A, DYKD1005500A, DYKD1005500M, DYKD1005532A, DYKD1005534B, DYKD1005549A, DYKD1005688A, DYKD1005914P, DYKD1005941A,
DYKD1005961A, DYKD1005961D, DYKD1005972A, DYKD1005972Y, DYKD1005972Y1, DYKD1006108A, DYKD1006195A2, DYKD1006211M, DYKD1006272A, DYKD1006558A, DYKD1006558P, DYKD1006766A2, DYKD1006841A, DYKD1006841A1, DYKD1006905A1, DYKD1006905A2, DYKD1006948P, DYKD1006954A, DYKD1006989A, DYKD1007145A, DYKD1007876A, DYKD1007876P, DYKD1007893A, DYKD1007893A1,
DYKD1007990P, DYKD1008000A, DYKD1008011A, DYKD1008182A, DYKD1008829A, DYKD1008869A, DYKD1008923A, DYKD1008978A1, DYKD1008978A2, DYKD1009010A, DYKD1009237A, DYKD1009261A, DYKD1009292A, DYKD1009292A1, DYKD1009301H,DYKD1009302A, DYKD1009305A, DYKD1009312A, DYKD1009315A, DYKD1009319A, DYKD1009319A1, DYKD1009319A2, DYKD1009326A, DYKD1009584A,
DYKD1009709A, DYKD1009709M, DYKD100COLP3, DYKD100COLP4, DYKD1010372A, DYKD1010731A, DYKD1010731A1, DYKD1010751A, DYKD1010766A, DYKD1010766A1, DYKD1010766M, DYKD1010855A, DYKD1011054OB, DYKD1011438A, DYKD1011555A, DYKD1011594A1, DYKD1011669A, DYKD1011857A, DYKD1011946A, DYKD1011946A2, DYKD1011946A3, DYKD1012070B, DYKD1012238P, DYKD1012288MH,
DYKD1012288P, DYKD1012291A, DYKD1012308A, DYKD1012308A1, DYKD1012341A, DYKD1012341A1, DYKD1012480A, DYKD1012612L1, DYKD1012713A, DYKD1012735A, DYKD1012738A, DYKD1012918A, DYKD1013192A, DYKD1013207A, DYKD1013214A, DYKD1013275A2, DYKD1013541A, DYKD1013541A1, DYKD1013579A, DYKD1013659A, DYKD1014173A1,DYKD1014185B1, DYKD1014781A, DYKD1014781A1,
DYKD1014997Y, DYKD1015016A, DYKD1015045A, DYKD1015051A, DYKD1015051P, DYKD1015127A, DYKD1015127A1, DYKD1015650A, DYKD1015650M, DYKD1015661A1, DYKD1015661M, DYKD1015711A, DYKD1015795A, DYKD1015831I, DYKD1015887A, DYKD1015887A1, DYKD1015898A, DYKD1016465A, DYKD1016555A, DYKD1016580A1, DYKD1016700A, DYKD1017001A, DYKD1017074A, DYKD1017177A,
DYKD1017369A, DYKD1017369L1, DYKD1017369LD, DYKD1017407A, DYKD1017407I, DYKD1017489A1, DYKD1017489A2, DYKD1017493N, DYKD1017550A, DYKD1017582A2, DYKD1017681A, DYKD1017783A,DYKD1018497A, DYKD1018497G, DYKD1018497G1, DYKD1018512B, DYKD1018512B1, DYKD1018513A, DYKD1018562A, DYKD1018563A1, DYKD1018578A, DYKD1018578A1, DYKD1018595D, DYKD1018595M,
DYKD1018595O, DYKD1018663AK, DYKD1019004A, DYKD1019249A, DYKD1019286A, DYKD1019455P, DYKD1019558A, DYKD1019580AM, DYKD1019580M1, DYKD1019743A, DYKD1020287A, DYKD1020325A, DYKD1020633A, DYKD1021267H, DYKD1021268A, DYKD1021310P, DYKD1021310P1, DYKD1021311A, DYKD1021323A, DYKD1021323A1, DYKD1021323A2, DYKD1021323A3, DYKD1021323P, DYKD1021323P1,
DYKD1021323P2, DYKD1021323P3, DYKD1021323Y, DYKD1021323Y1, DYKD1021323Y2, DYKD1021366A, DYKD1021642A, DYKD10216442A, DYKD1021850A, DYKD1021850M, DYKD1021850M1, DYKD1021856A,DYKD1021856M, DYKD1021856M1, DYKD1021856M2, DYKD1021865A, DYKD1021901A, DYKD1022012A, DYKD1022012A1, DYKD1022012M, DYKD1022012M1, DYKD1022012M2, DYKD1022109A1, DYKD1022109A2,
DYKD1022117N, DYKD1022117N1, DYKD1022117P, DYKD1022208A, DYKD1022208A1, DYKD1022665A, DYKD1022941A, DYKD1022941A1, DYKD1022941M, DYKD1022941M1, DYKD1022941M2, DYKD1022941M3, DYKD1022941M4, DYKD1023036P, DYKD1023131A1,DYKD1023151A1, DYKD1023188A, DYKD1023482A, DYKD1023550L, DYKD1023550L1, DYKD1023550PC, DYKD1023577A, DYKD1023674A, DYKD1023707A,
DYKD1023726A, DYKD1023733A, DYKD1023748A, DYKD1023766AE, DYKD1023776A, DYKD1023786A, DYKD1023790A, DYKD1023807A, DYKD1025559A, DYKD1027534A, DYKD1028186A, DYKD1029707A, DYKD1034131A, DYKD1039892A, DYKD1039911A, DYKD1039921A, DYKD1040105A, DYKD1041379A1, DYKD1041385A, DYKD1041862A, DYKD1044791A, DYKD1049313A, DYKD1057399C, DYKD1058359A,
DYKD1058359A1, DYKD1058363A, DYKD1058367A, DYKD1059698A1, DYKD1059826A, DYKD1059826A1,DYKD1062839M, DYKD1062839W, DYKD1064283A,DYKD1064364A, DYKD1064634A, DYKD1064917A, DYKD1065425A, DYKD1065545A, DYKD1065545M,DYKD1065545M1, DYKD1066509A, DYKD1066514A, DYKD1066514A1, DYKD1066514A2, DYKD1066514A3, DYKD1066514A4, DYKD1066577A1, DYKD1066618A,
DYKD1066618A1, DYKD1066705A, DYKD1066A, DYKD1067282A, DYKD1067282A1, DYKD1067380A, DYKD1067380A1, DYKD1067381A, DYKD1067387A, DYKD1067387A1, DYKD1067700M5, DYKD1067700M6, DYKD1067959A, DYKD1070075A, DYKD1070118A, DYKD1070118T, DYKD1071574A, DYKD1072153A, DYKD1072227A, DYKD1073231P, DYKD1074113N,DYKD1075210M, DYKD1075210M1, DYKD1075210M2,
DYKD1075641A, DYKD1077047A, DYKD1078243A, DYKD1078899A, DYKD1078899A1, DYKD1081924A, DYKD1082407A, DYKD1082407M, DYKD1082407M2,
DYKD1084108M, DYKD1084108M1, DYKD1084108M2,
DYKD1084144A1, DYKD1086294A, DYKD1086294M,
DYKD1089881A, DYKD11002A3, DYKD1101090A,
DYKD11081A, DYKD1150603A, DYKD1151108T,
DYKD1154308A, DYKD1154308A1, DYKD1154643A,
DYKD1165686C, DYKD1168572A, DYKD1175041A, DYKD1186A,
DYKD124357A1, DYKD139027A, DYKD14109A, DYKD14152A,
DYKD14320A, DYKD14320P, DYKD151105A, DYKD151194A,
DYKD151198A, DYKD151216A, DYKD151301A, DYKD151592A,
DYKD152262A2, DYKD15262A, DYKD15278A, DYKD15498A1,
DYKD15750A, DYKD16393A, DYKD17507MS1, DYKD19138A,
DYKD2004AD, DYKD2004BD, DYKD21139A, DYKD21630A,
DYKD22087AM, DYKD23083A, DYKD23093P, DYKD23141A,
DYKD23153A, DYKD25832A, DYKD26747A1, DYKD27788A,
DYKD32643P, DYKD39021M, DYKD4082M, DYKD43362A,
DYKD43557A3, DYKD44074A, DYKD44075A, DYKD44205A,
DYKD46334A, DYKD46437A, DYKD49572A, DYKD4970A1,
DYKD49892A2, DYKD50019A3, DYKD500318A, DYKD500318AX1,
DYKD50126A, DYKD50176A1, DYKD50620A, DYKD5081A,
DYKD5086A, DYKD51325A1, DYKD5241A, DYKD53043A,
DYKD53191A, DYKD53191P, DYKD54833A1, DYKD5539A,
DYKD5825A, DYKD5891A1, DYKD612A, DYKD61526A,
DYKD61599A, DYKD61682A, DYKD739102A, DYKD743415A,
DYKD751468A2, DYKD762320P, DYKD780210J, DYKD828200A,
DYKD90814OP, DYKD91272AD, DYKDG695A, DYKDG695A2,
DYKDN1008523A, DYKDN1011060A, DYKDN1011734A,
DYKDN1013307A, DYKDN1063571A, DYKDN1085549A,
DYKN1004256A1, DYKN1005518F1, DYKN1005386A,
DYKN1005386P, DYKN1005518M1, DYKN1005518M2,
DYKN10055386A, DYKN1006159A, DYKN1008064A,
DYKN1008608P, DYKN1009314A, DYKN1011012C,
DYKN1011012V, DYKN1011679M, DYKN1011734BP,
DYKN1012165M, DYKN1012171A, DYKN1014293A, DYKN1014293A1,
DYKN1014971A, DYKN1015466A, DYKN1016569A, DYKN1016569A1,
DYKN1019004A, DYKN1019004A1, DYKN1019004P,
DYKN1019004P1, DYKN1021944A, DYKN1022200P, DYKN1022384P,
DYKN1034134A, DYKN1040955M, DYKN1040955N, DYKN1040955N1,
DYKN1055656A, DYKN1064827A, DYKN1069704A, DYKN1069704A1,
DYKNPU1 and MSC095001H.The following kit reorder numbers contain 4 oz. bottles of lotion: DKY1172636A,
DYK1001650A1, DYK1001793A1, DYK1002287A, DYK1003138A1,
DYK1003944A, DYK1006383A, DYK1007893A3, DYK1007893A4,
DYK1007893A5, DYK1008064A1, DYK1008104A1, DYK1008847A1,
DYK1009304A, DYK1009904A, DYK1010581A, DYK1011034A,
DYK1011495A, DYK1011593A, DYK1011606A, DYK1011891A1,
DYK1011891M, DYK1011945B1, DYK1012026A, DYK1012119A,
DYK1012183P1, DYK1012232A1, DYK1012422H1, DYK1013275A3,
DYK1014493A, DYK1015258A, DYK1015258A1, DYK1015595A,
DYK1015836A, DYK1015836M, DYK1016989M, DYK1017582A3,
DYK1018503A, DYK1018514A, DYK1018533A1, DYK1019292A,
DYK1021652A, DYK1022117A1, DYK1022197A, DYK1022591A,
DYK1022591A1, DYK1023735A1, DYK1029682A, DYK1034130A,
DYK1040139A2, DYK1040139A3, DYK1040139A4, DYK1044978P1,
DYK1047595A, DYK1057519A, DYK1057519G, DYK1062678H,
DYK1065831A1, DYK1066128A, DYK1066646A, DYK1066646A1,
DYK1066658A, DYK1066666A, DYK1069400M, DYK1073114A,
DYK1077038A, DYK1077038A1, DYK1077257A, DYK1082600A,
DYK1088656A, DYK1090570W, DYK1100748A, DYK11199A2,
DYK1150235A, DYK1160184M, DYK1166218A, DYK1171804A1,
DYK1172636A, DYK1177716A, DYK1183936A, DYK1194815A,
DYKD1000841A, DYKD1000858A, DYKD1000907A, DYKD1000923A,
DYKD1001437A, DYKD1001650A, DYKD1001695A, DYKD1001793A,
DYKD1001808A, DYKD1001808A1, DYKD1001899M, DYKD1001A,
DYKD1002169T, DYKD1002348A, DYKD1002373A, DYKD1002375A,
DYKD1002907A, DYKD1002907A1, DYKD1002986M, DYKD1002A,
DYKD10030070A, DYKD1003070A, DYKD1003094, DYKD1003094A,
DYKD1003212A, DYKD1003632A, DYKD1003928G, DYKD1003938A,
DYKD1003938C, DYKD1003996A, DYKD1004094A, DYKD1004206F,
DYKD1004206M, DYKD1004212A, DYKD1004458A, DYKD1004506A,
DYKD1004577A, DYKD1004946A, DYKD1005411A, DYKD1005472A,
DYKD1005474A, DYKD1005478P, DYKD1005483A, DYKD1005941P,
DYKD1006085A1, DYKD1006110A, DYKD1006200A,
DYKD1006230A1, DYKD1006230M, DYKD1006372A, DYKD1006789M,
DYKD1006989P1, DYKD1007893A2, DYKD1008367A,
DYKD1008403A, DYKD1008744A, DYKD1008771A, DYKD1008817A,
DYKD1008830A, DYKD1008847A, DYKD1008852A, DYKD1008929A,
DYKD1008988A, DYKD1008988A1, DYKD1008988A2,
DYKD1008993A, DYKD1008993A1, DYKD1009018A,
DYKD1009018A1, DYKD1009081A, DYKD1009223A, DYKD1009309A,
DYKD1009309A1, DYKD1010115A, DYKD1010404C,
DYKD1010986P1, DYKD1011014A, DYKD1011054A, DYKD1011059A,
DYKD1011136F, DYKD1011136M, DYKD1011563M, DYKD1011563M1,
DYKD1011585A, DYKD1011671A, DYKD1011726A, DYKD1011885A,
DYKD1011909A, DYKD1011935A, DYKD1011945B, DYKD1012057A,
DYKD1012095A, DYKD1012163A, DYKD1012163A1, DYKD1012183P,
DYKD1012232A, DYKD1012288A, DYKD1012422H, DYKD1012726A,
DYKD1012728P, DYKD1013765A, DYKD1013770A, DYKD1014057A,
DYKD1014477A, DYKD1014534D1, DYKD1014894A2,
DYKD1014985A, DYKD1015077A, DYKD1015233A, DYKD1015595A2,
DYKD1015791B, DYKD1016104A, DYKD1016104A1, DYKD1016164M,
DYKD1016165A, DYKD1016469A, DYKD1017104M, DYKD1017362A,
DYKD1017362A1, DYKD1017362A2, DYKD1017488A,
DYKD1017488A1, DYKD1017493A, DYKD1017502A, DYKD1017518A,
DYKD1017922A, DYKD1017922A1, DYKD1018205A,
DYKD1018205A1, DYKD1018533A, DYKD1018541A,
DYKD1018541A1, DYKD1018542A, DYKD1018568A, DYKD1018585A,
DYKD1018732A, DYKD1018992A, DYKD1019268A, DYKD1019890A,
DYKD1020631A, DYKD1020880A, DYKD1021268P4,
DYKD1021278M, DYKD1021411A, DYKD1021834A,
DYKD1022207A1, DYKD1022117A, DYKD1022207M,
DYKD1022211A, DYKD1022397A, DYKD1022440A,
DYKD1022486A, DYKD1022486A1, DYKD1022597A, DYKD1022610A,
DYKD1022643P, DYKD1022868A, DYKD1023535M1,
DYKD1023550L, DYKD1023560P, DYKD1023658A1,
DYKD1028626A, DYKD1035A, DYKD1040139A,
DYKD1040139A1, DYKD1044978P, DYKD1045425A,
DYKD1045457A, DYKD1045954A, DYKD1046741A1,
DYKD1047792A, DYKD10513A, DYKD10513I, DYKD1051400M,
DYKD1055671A, DYKD1057519A, DYKD1058363A1,
DYKD1059923A, DYKD1062084A, DYKD1062861A, DYKD1064832A,
DYKD1065503A, DYKD1065831A, DYKD1066473A,
DYKD1066637PY, DYKD1067490A, DYKD1067490A1,
DYKD1069268A, DYKD1069439A, DYKD1069585A,
DYKD1081765D, DYKD1081765P, DYKD1083475A, DYKD1084904A,
DYKD10914A, DYKD1094391A, DYKD11199A1, DYKD1157310A,
DYKD1157310A1, DYKD1159847M, DYKD11623A, DYKD1165052A,
DYKD11685A, DYKD1171804A, DYKD12311A1, DYKD14135AX,
DYKD14169A1, DYKD14184A, DYKD14613A1, DYKD151317A,
DYKD152249H, DYKD15278PSY, DYKD15630A1, DYKD15792A,
DYKD162S1, DYKD17190A1, DYKD21124A, DYKD21366A1,
DYKD22038A, DYKD23290A, DYKD2540A, DYKD29085A,
DYKD29395A, DYKD3009AP1, DYKD31095A, DYKD31453A,
DYKD32847A, DYKD33118A1, DYKD33160A1, DYKD406281A,
DYKD41512A1, DYKD42378A, DYKD43240A1, DYKD43387A2,
DYKD44302A2, DYKD494806A, DYKD500318AX, DYKD5048A,
DYKD520276A, DYKD53139A, DYKD5627A, DYKD56443A,
DYKD57117M, DYKD58922A, DYKD61586B, DYKD63249A,
DYKD64737A, DYKD64737AM, DYKD6719A, DYKD711091AX,
DYKD712608A1, DYKD712608A2, DYKD715748A, DYKD715990A,
DYKD7263A1, DYKD7323A, DYKD744274A, DYKD748223P,
DYKD753049AX1, DYKD805002A, DYKD832499A, DYKD90814A,
DYKG1407A, DYKN1000883A, DYKN1000927A, DYKN1001450A,
DYKN1005518S, DYKN1005518S1, DYKN1007881A,
DYKN1007881A1, DYKN1008608A, DYKN1010991A, DYKN1011935A,
DYKN1012025A, DYKN1012379A, DYKN1013490A, DYKN1013493A,
DYKN1016652A, DYKN1020908A, DYKN1034127A, DYKN1044932I,
DYKN1044978P, DYKN1066481A, DYKN1070589A, DYKN1070589A1,
DYKN1070841A, DYKN1078288A, DYKN1097943A
and MSC095004H;
c) All bottle lots beginning with a "3" or 4001,
4002, 4003, 4004, 4005, 4006, 4007, 4008,
or have no lot number. The following kit reorder
numbers contain the 3.5 oz bottles: DYKD1013275A2,
MSC090472H and MSC090474H;
d) All bottle lots beginning with a "3" or 4001,
4002, 4003, 4004, 4005, 4006, 4007, 4008, or
have no lot number. The following kit reorder
numbers contain 2 oz. bottles of baby oil:
DYK1004385B, DYK10223668B, DYK1022368B,
DYK1082407I1, DYKD1005919B2, DYKD1006195N1,
DYKD1006948B, DYKD1011944BC, DYKD1021267H,
DYKD1022BW, DYKD1070118I, DYKD1082407I,
DYKD1166040N, DYKN1015466N, DYK1005919B3 and
DYK1022368B1
The following kit reorder numbers contain 4 oz. bottles of baby oil: DYKD1023674B, DYKD1034163N, DYKD1046741A, DYKD1046741A1, DYKD1074113N, DYKD1084904A, DYKD1087914A, DYKD15278P, DYKD39254B1, DYKD55021B and MSC095052H.
RECALLING FIRM/MANUFACTURER
Medline Industries, Inc., Mundelein, IL, by letters dated March 29, 2004. Firm initiated recall is complete.
REASON
Lotions and oils are contaminated with Burkholderia cepacia, and fungus respectively.
VOLUME OF PRODUCT IN COMMERCE
2,443,750 bottles, 1,461,300 kits.
DISTRIBUTION
Nationwide and Internationally.
-
December 22 , 2004 John Frieda, Frizz Ease 5-Minute Manager Blow Dryer Styling Spray
- December 22, 2004
PRODUCT
John Frieda, Frizz Ease 5-Minute Manager Blow Dryer Styling Spray in 6.7 oz. (200mL) plastic bottle with pump sprayer, packaged 6 bottles per case. Recall # F-106-5.
CODE
Lot #S025AS064
-
December 8 , 2004 Top Care
- December 08, 2004
PRODUCT
a) Top Care
-
October 13 , 2004 Breath-eze Breath and Gas Relief Tablets for Dogs
- October 13, 2004
PRODUCT
Breath-eze Breath and Gas Relief Tablets for Dogs (activated charcoal, simethicone). Recall # V-186-4.
CODE
Lot PJ315.
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc., Fort Worth, TX, by telephone on August 26, 2004, and by fax on September 7, 2004. Firm initiated recall is ongoing.
REASON
Product contains Breath-eze chewable breath mints which have no active ingredient for gas relief.
VOLUME OF PRODUCT IN COMMERCE
2,100 units.
DISTRIBUTION
PA, MA, OH, NJ, AZ, NC, NE, and Canada.
-
September 22 , 2004 Pantene PRO-V shampoo (various)
- September 22, 2004
PRODUCT
a) Pantene PRO-V shampoo Hydrating Curls, 400 mL (13.5 fl oz.). Shampoo is packaged in a plastic bottle. UPC 80878-00451. Recall # F-446-4;
b) Pantene PRO-V shampoo Classic Clean, 400 mL (13.5 fl oz.). Shampoo is packaged in a plastic bottle. UPC 80878-00452. Recall # F-447-4;
c) Pantene PRO-V shampoo Smooth & Sleek, 400 mL (13.5 fl oz.). Shampoo is packaged in a plastic bottle.UPC 80878-00448. Recall # F-448-4;
d) Pantene PRO-V shampoo Color Revival, 400 mL (13.5 fl oz.). Shampoo is packaged in a plastic bottle. UPC 80878-00449. Recall # F-449-4;
e) Pantene PRO-V shampoo Clarifying, 400 mL (13.5 fl oz.). Shampoo is packaged in a plastic bottle. UPC 80878-00453. Recall # F-450-4;
f) Pantene PRO-V shampoo Regular, 400 mL (13.5 fl oz.). Shampoo is packaged in a plastic bottle. UPC 80878-00463. Recall # F-451-4.
CODE
a) Manufacturer
-
September 1 , 2004 C.E.T. Home Dental Care Oral Hygiene Gel for Dogs and Cats
- September 01, 2004
PRODUCT
C.E.T. Home Dental Care Oral Hygiene Gel for Dogs and Cats, NDC 051311-502-32, 1.4 fl. Oz. (32 mL). 0.12% Chlorhexidine Gluconate. Recall # V-164-4.
CODE
All lots of the product on the market are being recalled . The subpotent lots are WF363, WF313, WH352, WL307, and WC433.
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc., Fort Worth, TX, by letter on July 14, 2004. Firm initiated recall is ongoing.
REASON
Subpotency.
VOLUME OF PRODUCT IN COMMERCE
88,366 units.
DISTRIBUTION
Nationwide
-
September 1 , 2004 Sebolux Medicated Shampoo for Dogs and Cats & Epi-Otic Ear Cleanser for dogs, cats, puppies, and kittens
- September 01, 2004
PRODUCT
a) Sebolux Medicated Shampoo for Dogs and Cats, Antiseborrheic Keratoplastic, 8 fl. Oz., Active Ingredients: Solubilized Sulfur (equivalent to 2%
elemental Sulphur) and 2% salicylic acid. Recall # V-162-4;
b) Epi-Otic Ear Cleanser for dogs, cats, puppies, and kittens. Cleansing, drying, non-irritating. Recall # V-163-4.
CODE
a) and b) WJ363.
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc., Fort Worth, TX, by telephone on July 15, 2004. Firm initiated recall is ongoing.
REASON
Bottles labeled at Sebolux Medicated Shampoo for dogs and cats contain EPI-Otic Ear Cleanser for Dogs, Cats, Puppies, and kittens.
VOLUME OF PRODUCT IN COMMERCE
22,824 units.
DISTRIBUTION
Nationwide
-
September 1 , 2004 Clare Burke Lathering Scrubs
- September 01, 2004
PRODUCT
a) Clare Burke, Blushing Rose Lathering Scrub, 8 oz., Recall # F-370-4;
b) Claire Burke Lathering Scrib, Original Scent, 8 oz. Recall # F-371-4.
CODE
a) Product Codes 08125.041 and 08125.F41;
b) Product Codes 08125.085, 08125F85.
RECALLING FIRM/MANUFACTURER
Esscentual Brands Inc, Scottsdale, AZ, by letters on May 20, 2004. Firm initiated recall is ongoing.
REASON
Lathering Scrubs have high pH.
VOLUME OF PRODUCT IN COMMERCE
Not able to be determined.
DISTRIBUTION
Nationwide and Internationally.
-
June 16 , 2004 Colgate Fluoride Toothpaste
- June 16, 2004
PRODUCT
a) Colgate Fluoride Toothpaste, Maximum Cavity Protection, (Sodium Monofluorophosphate 0.76% (1000ppm F) and Sodium Fluoride 0.1% (450ppm F)), packaged in 100-ml tubes, net wt. 5 oz., Regular Flavour. Recall # D-186-4.
b) Colgate Fluoride Toothpaste Triple Action, (1.10% Sodium Monofluorophosphate and 0.20% Triclosan) packaged in 100-ml. tubes, net wt. 5-oz. Recall # D-187-4;
c) Mentadent P, Fluoride Toothpaste, (0.74% Sodium Mono-Fluorophosphate), packaged in 100-ml. tubes, Net Wt 5 oz. Recall # D-188-4;
d) Colgate Fluoride Toothpaste, Herbal, (1.10% Sodium Monofluorophosphate, packaged in 100-ml. tubes, NET WT 5 oz. Recall # D-189-4;
e) Aquafresh Fluoride Toothpaste, (Sodium Monofluorophosphate 0.76% w/w), packaged in 100-ml.tubes, 5 OZ. Recall # D-190-4.
CODE
a) All Lots: South African labeling SKU: 458976;
b) All Lots: South African labeling SKU: 445077;
c) All Lots: South African labeling SKU: 458977;
d) All Lots: South African labeling SKU: 460361;
e) All Lots: South African labeling SKU: 418030.
RECALLING FIRM/MANUFACTURER
Deals Nothing Over A Dollar, Earth City, MO, by letters on March 3, 2004 and email on March 11, 2004. Firm initiated recall is complete.
REASON
Misbranded; labeling is not in compliance with regulations.
VOLUME OF PRODUCT IN COMMERCE
Approximately 50,000 tubes.
DISTRIBUTION
Nationwide
-
June 16 , 2004 Orasept Antiseptic Mouthwash & Gargle
- June 16, 2004
PRODUCT
Orasept Antiseptic Mouthwash & Gargle (cetylpyridinium HCl 0.05% w/w), 4 fl. oz. (118 mL) bottles, over-the-counter. NDC 55422-202-04. Recall # D-182-4.
CODE
Lot 4B45, Expiration Date 01/06.
RECALLING FIRM/MANUFACTURER
Pharmakon Laboratory, Inc., Tampa, FL, by letter on April 19, 2004. Firm initiated recall is ongoing.
REASON
Microbial contamination (yeast and mold).
VOLUME OF PRODUCT IN COMMERCE
9,754 bottles.
DISTRIBUTION
PA, GA, and CT.
-
March 24 , 2004 John Frieda Hair Sprays
- March 24, 2004
PRODUCT
Sheer Blond Curvaceous Blonde 6.7 fluid ounces pump spray, sold only at Eckerd stores in the states of Delaware, Maryland, New Jersey, Pennsylvania and Virginia. The Eckerd stores who received the indicated lots have been notified and are pulling the product from their shelves.
CODE
The product recall is limited to the following lot codes: S001AW037 and S001AW040. The code is printed on the bottom of the bottle.
RECALLING FIRM/MANUFACTURER
Recalling Firm: John Frieda Professional Hair Care, Inc. (toll free hotline at 1-800-521-3189, 8am - 5pm M-F, EST)
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
REASON
The voluntary recall was initiated after routine testing revealed a possible contamination with Pseudomonas, a bacterium which can cause infections in an open wound or cut in rare circumstances. The infections are easily treated with antibiotics and usually do not represent a serious health effect.
VOLUME OF PRODUCT IN COMMERCE
104 cases (624 bottles)
DISTRIBUTION
Delaware, Maryland, New Jersey, Pennsylvania and Virginia
-
December 10, 2003 The Skin Culture One Day Peeling Treatment and The 6 Day Cosmetic Facial Treatment Kit
- December 10, 2003
PRODUCT
a) The Skin Culture One Day Peeling Treatment. 6 Treatments: 6 Cerate 39XXX, 6 Normalizer Applicators, Jar. Recall # D-024-4;
b) Skin Culture 2 Peeling Treatment, Skin Creams, The 6 Day Cosmetic Facial Treatment Kit. Recall # D-025-4;
c) Skin Culture 3 Peeling Treatment, Skin Creams. The 6 Day Cosmetic Facial Treatment Kit. Recall # D-026-4;
d) Skin Culture 4 Peeling Treatment, Skin Creams. The 6 Day Cosmetic Facial Treatment Kit. Recall # D-027-4.
CODE
a) Lots 11132, and 11829;
b) Lot 27652;
c) Lot 28132;
d) Lot 37522.
RECALLING FIRM/MANUFACTURER
Skin Culture Institute, Inc., New York, NY, by letter and fax on October 1, and October 2, 2003. FDA initiated recall is ongoing.
REASON
Misbranding: Product fails to contain declared ingredient Resorcinol and is subpotent for its sulfur ingredient.
VOLUME OF PRODUCT IN COMMERCE
Approximately 4,000 jars.
DISTRIBUTION
Nationwide.
-
December 10, 2003, Pert Plus, 2 in 1 Dandruff Control Shampoo plus Conditioner
- December 10, 2003
PRODUCT
Pert Plus, 2 in 1 Dandruff Control Shampoo plus Conditioner (Pyrithione zinc 1.0%), 13.5 Fl. Oz. (400 mL), 12 bottles per case. Recall # D-071-4.
CODE
Lot Numbers: 32765395XA and 32885395XA.
RECALLING FIRM/MANUFACTURER
The Proctor & Gamble Company, Cincinnati, OH, by telephone on October 27, 2003. Firm initiated recall is ongoing.
REASON
Subpotent for Pyrithione Zinc ingredient.
VOLUME OF PRODUCT IN COMMERCE
1,374 cases.
DISTRIBUTION
Nationwide.
-
November 26, 2003 Don't Be Bald Hair Care Treatment, Medicated; BBD 1854 Dandruff Shampoo; and Don't B Bald, Scalp Stimulate
- November 26, 2003
PRODUCT
a) DON'T BE BALD Hair Care Treatment, Medicated, "THE ORIGINAL FORMULAS", Net. Wt. 4 oz. Jars. Recall # D-065-4;
b) BBD 1854 Dandruff Shampoo, For Professional Use Only, Anti-Dandruff Conditioning Shampoo, 8 Fl. Oz. bottles (24 Liters). Recall # D-066-4;
c) Don't B Bald, Scalp Stimulate, Organic Formula, 4 Fl. Oz. (118 mL) Jars. Recall # D-067-4.
CODE
a) Batch numbers: 55, 64, and 69; b) Batch number: 10269;
c) Batch numbers: 020800, 53.
RECALLING FIRM/MANUFACTURER
Pride and Power, Inc., Houston, TX, by letter on September 30, 2003. FDA initiated recall is ongoing.
REASON
Unapproved New Drug.
VOLUME OF PRODUCT IN COMMERCE
5,580 containers.
DISTRIBUTION
Nationwide.
-
August 6, 2003 Ray Block Sunscreen Lotion, SPF 15
- August 06, 2003
PRODUCT
Ray Block Sunscreen Lotion, (Octyl Dimethyl PABA 5% and Benzophenone 3.3%) SPF 15, 1 FL OZ (29.6mL) and 4 FL OUNCES (118.3 mL). Recall # D-282-3.
CODE
Lot D32, expiration date 04/05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Crown Laboratories, Inc., Johnson City, TN, by letters on June 5, 2003.
Manufacturer:
DEL-RAY LABS, INC., Birmingham, AL. Firm initiated recall is ongoing.
REASON
Superpotent; octyl dimethyl PABA and oxybenzone.
VOLUME OF PRODUCT IN COMMERCE
319-4 oz and 324-1 oz bottles.
DISTRIBUTION
Nationwide.
-
July 9, 2003 Coppertone Bug & Sun Sunscreen with Insect Repellent, SPF 30, Kid's Formula
- July 09, 2003
PRODUCT
a) Coppertone_ Bug & Sun Sunscreen with Insect Repellent, (N, N-diethyl-m-toluamide 9.5% and other isomers 0.5%), SPF 30, Kid's Formula, 4 FL OZ (118mL) and 8 FL OZ (237mL) bottles. Recall # D-271-3;
b) Coppertone_ Bug & Sun Sunscreen with Insect Repellent, (N,N-diethyl-m-toluamide 9.5% and other isomers 0.5%), SPF 30, Kid's Formula, 8 FL OZ (237mL) bottles. Recall # D-272-3.
CODE
a) 2D01PM, 2P02PM, and 3A01PM;
b) 1J01PM, 1M05PM, 1M01PM, 1M06PM, 1M05PM, 1M05APM, 1M04PM, 1N01PM, 1N06PM, 1N05PM, 1N04PM, 1N03PM, 1N02PM, 2A08PM, 2A04PM, 2A03PM, 2A02PM, 2A01PM, 2D03PM, 2E01PM, 2H01PM, 2J02PM, 2J01PM, 2K03PM, 2K02PM, 2K01PM, 2M01PM, 2N01PM, 2P01PM, 3A04PM, 3A02PM, 3B06PM, 3B01PM, 3B05PM, 3B04PM, 3B03PM, M312005/3B06PM, M312005A, M312005B, M312105, 3C02PM, 3C01PM, and 3C03PM.
RECALLING FIRM/MANUFACTURER
Prime Enterprises, Inc., Miami Lakes, FL, by letters on May 30, 2003.
REASON
a) These lots contain trace quantities of an additional sunscreen, benzophenone-4, which were incorrectly added to the formulation.
b) Certain lots of product may contain undeclared preservative.
VOLUME OF PRODUCT IN COMMERCE
902,519 units.
DISTRIBUTION
Nationwide.
-
July 2, 2003 Chunkie Face Paints
- July 02, 2003
PRODUCT
a) Chunkie Face Paints 4-Pack packed in four plastic squeezable tube applicator bottles with a cap and a soft brush tip and four different colored tubes (white, red, yellow and blue). Recall # F-407-3;
b) Chunkie Face Paints 4-Pack packed in four plastic squeezable tube applicator bottles with a cap and a soft brush tip and four different colored tubes (white, red, black and green). Recall # F-408-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Publix Super Markets, Lakeland, FL, by e-mail on February 19, 2003.
Manufacturer: Bluepath Industries, LTD, Edmonton, Alberta, Canada. FDA initiated recall is ongoing.
REASON
Both products contain D&C Red No. 7, a color that was not approved for use as a cosmetic in close proximity of the eye as shown in the vignette.
VOLUME OF PRODUCT IN COMMERCE
360 cases/6 per case.
DISTRIBUTION
FL.
-
November 20, 2002; Pyrethrin Lice Treatment, Kinray Preferred Plus brand, A Creme Rinse Application
- November 20, 2002
PRODUCT
Pyrethrin Lice Treatment (Piperonyl Butoxide 4% and Pyrethrum Extract (equivalent to 0.33% Pyrethrins), Kinray Preferred Plus brand, A Creme Rinse Application, 2 fl. oz. (59 mL) bottles, single and twin packs. Recall # D-054-3.
CODE
2F15A, exp. June 2004 (single unit)
2G02A, exp. July 2004 (twin pack)
2G25D, exp. July 2004 (twin pack).
RECALLING FIRM/MANUFACTURER
Qualis, Inc., Des Moines, IA, by telephone on October 28, 2002. Firm initiated recall is ongoing.
REASON
Mislabeling; one active ingredient is incorrectly declared on the bottle label as Permethrin rather than correctly as Pyrethrin.
VOLUME OF PRODUCT IN COMMERCE
504 single units and 384 twin packs; 118 single packs and 245 twin packages have been quarantined at the own-label distributor awaiting return to Qualis.
DISTRIBUTION
NY
-
November 13, 2002 Paradise Gold SUNSCREEN BROAD SPECTRUM PROTECTANT
- November 13, 2002
PRODUCT
Paradise Gold SUNSCREEN BROAD SPECTRUM PROTECTANT
(Octinoxate, Octisalate, Oxybenzone, Avobenzone), SPF 15, 8 FL OZ (237 mL), Exclusively at Walgreens, Deerfield, IL. Recall # D-046-3.
CODE 2096B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tanning Research Laboratories, Inc., Ormond Beach, FL, by letter on July 11, 2002.
Manufacturer: Tanning Research Laboratories, Ormond Beach, FL. Firm initiated recall is complete.
REASON
Mislabeling; back label on bottle incorrectly declared as SPF 30 rather than the correct SPF 15.
VOLUME OF PRODUCT IN COMMERCE
5400
DISTRIBUTION
IL, WI, FL, TX, CA, PA, AZ and IN.
-
NOVEMBER 6, 2002 Hartz Advanced Care Brand Flea Control Capsules
- November 06, 2002
PRODUCT
Hartz Advanced Care Brand Flea Control Capsules (s)-Methoprene with 8 capsules per package and 154 milligram per capsule for dogs and puppies 9 weeks of age or older weighing 11 to 15 lbs. Recall # V-005-3.
CODE
Product Code: 32700-96718 Lot No.: 616601, Exp. Date June 14, 2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Hartz Mountain Corp., Secaucus, NJ, by telephone on July 15, 2002. Manufacturer: The Hartz Mountain Corp., Bloomfield, NJ. Firm initiated recall is ongoing.
REASON
Labeling and insert contained wrong body weight information.
VOLUME OF PRODUCT IN COMMERCE
18105 units.
DISTRIBUTION
Nationwide.
-
October 2, 2002 Listerine Essential Care Gel Toothpaste and Listerine Essential Care Tartar Control Gel Toothpaste
- October 02, 2002
PRODUCT
a) Listerine Essential Care Gel Toothpaste, 0.9 oz tube (Eucalyptol 0.738%, Menthol 0.340%, Methyl salicylate 0.480%, Thymol 0.511%, Sodium monofluorophosphate 0.76% (0.13% Fluoride Ion). Recall # D-422-2;
b) Listerine Essential Care Tartar Control Gel Toothpaste, 0.9 oz tube, (Eucalyptol 0.738%, Menthol 0.340%, Methyl salicylate 0.480%, Thymol 0.511%, Sodium monofluorophosphate 0.76% (0.13% Fluoride Ion). Recall # D-423-2.
CODE
All Lots packaged as follows:
Professional Samples -- Not for Retail Sale
Trial Size Tartar Control Gel Case UPC 1 03 12547 43450 5
Case containing 72/0.9 ounce tubes
Trial Size Gel
Case UPC 1 03 12547 43470 3
Case containing 72/0.9 ounce tubes.
Promotional Items as an on-pack with Listerine 1.0 L and 1.5 L (Gold, CoolMint, Fresh Burst, Tartar Control, Mixed Displays) Bottles.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer, Consumer Healthcare Group, Morris Plains, NJ, by letters on May 22, 2002.
Manufacturer: Accupac, Inc., Mainland, PA. Firm initiated recall is ongoing.
REASON
Subpotent; active ingredient Methyl salicylate (stability).
VOLUME OF PRODUCT IN COMMERCE
12,649,365 tubes.
DISTRIBUTION
Nationwide and Puerto Rico.
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September 18, 2002 Aura Cacia Rich Moisturizing Shampoo-2002
- September 18, 2002
PRODUCT:
Aura Cacia Rich Moisturizing Shampoo packaged in 12 and 32-fl. oz. bottles. Recall # F-756-2.
CODE:
12-oz. bottles - Lots 2170 and 2171
32-oz. bottles - Lots 2171 and 2172.
RECALLING FIRM/MANUFACTURER:
Recalling Firm: Frontier Natural Brands, Norway, IA, by telephone on July 12, 2002. Firm initiated recall is ongoing. REASON:
The product is contaminated with Enterobacter gergoviae.
VOLUME OF PRODUCT IN COMMERCE:
5,752 bottles.
DISTRIBUTION:
Nationwide and Canada.
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August 28, 2002 GOJO Skin Lotion Medicated-2002
- August 28, 2002
PRODUCT:
GOJO Skin Lotion Medicated (Allantoin 0.7%), 5 fl oz tubes NET 148 mL. Recall # D-388-2. The catalog numbers and packaging configuration are as follows: #8140-24 (case of 24); #8140-24-B5P00 (case of 24); #8140-06-BH200 (case of 6); #8140-12-BYR00 (case of 12)
CODE LOT NUMBERS:
134239, 138256, 147523, 151914, 152499, 153752, 160436, 169565, 170833.
RECALLING FIRM/MANUFACTURER:
GOJO Industries, Inc., Cuyahoga Falls, OH, by fax on July 25, 2002. Firm initiated recall is ongoing.
REASON
Subpotent; active ingredient Allantoin (stability).
VOLUME OF PRODUCT IN COMMERCE:
12,719 cases.
DISTRIBUTION:
Nationwide.
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May 29, 2002 Royal Jelly Milk Balm Moisture Lotion-2002
- May 29, 2002
PRODUCT
Royal Jelly Milk Balm Moisture Lotion, 1 oz. and 1.7 oz. For Dry to Normal Skin. Recall # F-447-2.
CODE
Lots: UU1295B, UU1295A, UU1285A, UU1198B, UU1198A.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Jafra Cosmetics International, Westlake Village, CA, by letters on March 1, 2002. Manufacturer: Universal Packaging Systems, Inc. Chino, CA. Firm initiated recall is complete.
REASON
The product was contaminated with Burkholderia cepacia. VOLUME OF PRODUCT IN COMMERCE
33,389.
DISTRIBUTION
Nationwide.
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April 17, 2002 PROVON Medicated Lotion Soap (GoJo)
- April 17, 2002
PRODUCT
PROVON Medicated Lotion Soap with Triclosan, OTC, packaged in 12 fl. oz. white plastic bottles. Active ingredient: Triclosan 0.3%, Product Number 4153-12. The bottles are packaged under the GOJO brand label. Recall # D�238-2. A case contains 12-12 fl oz bottles with a pump closure in cardboard box.
CODE
Lots #169738 and #168862.
RECALLING FIRM/MANUFACTURER
GOJO Industries, Inc., Cuyahoga Falls, OH, by fax on March 29, 2002. Firm initiated recall is ongoing.
REASON
Misbranding: Back bottle label declares incorrect active ingredient.
VOLUME OF PRODUCT IN COMMERCE
37 cases.
DISTRIBUTION
WI, IL, WA, MO, NE, LA, MA, and CA.
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April 17, 2002 HAND MEDIC Antiseptic Skin Treatment-2002
- April 17, 2002
PRODUCT
HAND MEDIC Antiseptic Skin Treatment, OTC, packaged in 500 ml cartridges, and 2 oz, 4 oz, and 8 oz bottles. Active ingredient: Benzalkonium Chloride 0.1%. Recall # D-237-2. The 500 ml cartridges are sealed poly bags inside a rectangular cardboard box, 6 per case. All bottles are black plastic, 12 per case (2 oz & 4 oz bottles), or 6 per case (8 oz bottles). The 500 ml cartridges, and the 4 oz and 8 oz bottles are packaged under the GOJO brand label; and the 2 oz bottles are packaged under either the GOJO brand or Pro-Link brand labels. The product catalog numbers are as follows: #8242-06 (500 ml cartridges); #8142-12 (2 oz); #8147-12 (4 oz); #8145-06 (8 oz)
CODE
Lot Numbers: 165461, 166095, 166581, 166826, 167503, 168453, and 168912.
RECALLING FIRM/MANUFACTURER
GOJO Industries, Inc., Cuyahoga Falls, OH, by fax on March 26, 2002. Firm initiated recall is ongoing.
REASON
Superpotency of the active ingredient (Benzalkonium Chloride).
VOLUME OF PRODUCT IN COMMERCE
9,703 cases.
DISTRIBUTION
Nationwide.
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MARCH 6, 2002 Rejuvenating Mist, manufactured for Soroko Blade Laboratories
- March 06, 2002
PRODUCT
Rejuvenating Mist, Manufactured for Soroko Blade Laboratories, Made in Canada. Recall # F-298-2.
CODE
All products on the market at the time the recall was initiated (the product was not coded).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Soroko Inc., Clifton, NJ, by letters on Jan. 9, 2001. Manufacturer: Elga Laboratories Ltd., Downview, Ontario, Canada. Firm initiated recall is complete.
REASON
Rejuvenating Mist was contaminated with Pseudomonas sp.
VOLUME OF PRODUCT IN COMMERCE
250 x 3.3 ounce spray bottles and an undetermined number of 2 oz. bottles.
DISTRIBUTION
NY, NJ, TX, Mexico, Scotland and Canada.
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February 27, 2002 Physicians Formula, Eye Makeup Remover Lotion-2002
- February 27, 2002
PRODUCT
Physicians Formula, Eye Makeup Remover Lotion, 2 Fl. Oz./ 59 ml., Recall # F-299-2.
CODE
Batch Code 0821 and 0601.
RECALLING FIRM/MANUFACTURER
Pierre Fabre/Physicians Formula Cosmetics, Azusa, CA, by press release on June 8, 2001 and by fax and letters on June 11, 2001. Firm initiated recall is complete.
REASON
The product was contaminated with Pseudomonas fluorescens/putida.
VOLUME OF PRODUCT IN COMMERCE
16,300 units.
DISTRIBUTION
Nationwide.
-
January 16, 2002 Anti-Aging Wrap solution
- January 16, 2002
PRODUCT
Anti-Aging Wrap solution, 8 oz., 32 oz. and 36 oz. plastic bottles. (conditioned water plus a proprietary blend of sodium magnesium and potassium salts, boron and other naturally occurring trace elements and herbal essences), Recall # D-070-2.
CODE
All Codes labeled as "Anti-Aging Wrap" that were distributed from 10/1/00 through 10/1/01 including lot #'s AA439090500 and AA110101CS.
RECALLING FIRM/MANUFACTURER
Recalling Firm: VMM Enterprises, Inc. Clearwater, FL , by letter on Oct. 8, 2001. Manufacturer: Pyramid Consulting and Investiment Co., Inc. Clearwater, FL. FDA initiated recall is ongoing.
REASON
Microbial Contamination; product is contaminated with Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide