U.S. Food and Drug Administration Recalls

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. 

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

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

FDA Alerts Consumers to Recall of Water-Based Face Paints
Fun Express, Inc. recalls children

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.

FOR IMMEDIATE RELEASE --Little Ferry, NJ, April 08, 2009, Castillo Distributor Inc has announced the voluntary recall all the products Monell

FOR IMMEDIATE RELEASE -- Easton, Maryland

FOR IMMEDIATE RELEASE -- GALLATIN, TN, November 13, 2008

FOR IMMEDIATE RELEASE -- Fort Washington, PA (November 7, 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.

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

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

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.

PRODUCT
L

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 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

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.

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

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

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

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

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

The Colgate

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

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

PRODUCT
Artificial Tears Lubricant Eye Drops,

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

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

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

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

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

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

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

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

PRODUCT
Systane

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

PRODUCT 
Tattoo Ink: Starbrite brand Black Magic Color, packaged in individual 1

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.

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

PRODUCT 
a) Top Care

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.

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

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

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

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.

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

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.

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

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. 

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. 

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.

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. 

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. 

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.

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 

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. 

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. 

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. 

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.

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.

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. 

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. 

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.

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. 

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.

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