FDA Warns Consumers Not to Use Skin Products Made by Clarcon Due to Bacterial Contamination Risk

The U.S. Food and Drug Administration announced June 8 that Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection. The FDA is warning consumers to not use any Clarcon products.

Consumers should not use any Clarcon products and should throw these products away in household refuse. Analyses of several samples of over-the-counter topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage. Examples of products that should be discarded include:

Citrushield Lotion

Dermasentials DermaBarrier

Dermassentials by Clarcon Antimicrobial Hand Sanitizer

Iron Fist Barrier Hand Treatment

Skin Shield Restaurant

Skin Shield Industrial

Skin Shield Beauty Salon Lotion

Total Skin Care Beauty

Total Skin Care Work

Findings from the FDA’s recent inspection of the Clarcon facility are particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases. The inspection uncovered serious deviations from FDA’s current Good Manufacturing Practice requirements.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

--Online
--Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: 800-FDA-0178
--Phone: 800-FDA-1088

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Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover

Celeste Industries Corporation has voluntarily recalled all lots of simplySmart™ "Remove" Make Up Remover in the US and Canada This product is packaged as a single towelette with hiexpress.com shown on the packet. This recall was a result of certain limited lots testing positive for Pseudomonas aeruginosa bacteria.

The organism Pseudomonas aeruginosa may cause serious eye infections, respiratory infections, dermatitis, soft tissue infections, bacteremia, and a variety of systemic infections, particularly in patients who are immunosuppressed. Because the Make-Up Remover may be used in the area of the eye, there is a possibility that inadvertent introduction of the tainted product directly in the eye could result in serious eye infections.

No illnesses have been reported to date in connection with this problem. The issue was discovered after a consumer complained of an odor coming from the towelette packets.

This product is not sold in the retail market but is provided as a guest amenity at Holiday Inn Express® hotels in the United States in Canada.

Celeste Industries ceased production of the product on October 5, 2008 and subsequently notified the distributor and the Food and Drug Administration

Any hotel guests who may have taken the product are advised to not use the product and to destroy it immediately. Consumers who have used the product and have any concerns should contact a healthcare professional.

Celeste Industries has identified the source of the contamination and will take all necessary steps to prevent future contamination when production of the product is resumed.

Consumers with questions regarding the recall should contact Celeste Industries Corporation at 410-822-6200, ext 1349 between 8:00 a.m. and 5:00 p.m. EST and ask for Quality Assurance or e-mail at recall@celestecorp.com. This recall is being made in cooperation with the Food and Drug Administration.

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L’Oréal Initiates Nationwide Recall of L’Oréal Paris Dream Blonde Bleach and Lightening Care Kit Due to Misprinted Directions

L'Oréal Paris, a division of L'Oréal USA, has initiated a voluntary recall from retail stores in the United States for the L'Oréal Paris Dream Blonde (Baby's 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'Oréal is voluntarily taking this action due to an error in the printing of the directions for the use of the Dream Blonde Bleach and Lightening care kit. All retailers have been notified and have removed the product from their shelves. Affected consumers, estimated at a few hundred, will receive a full refund for returned product.

L'Oréal took immediate action following one customer complaint of the product causing irritation. The Dream Blonde Bleach and Lightening Care formula itself is safe. However, if used according to the current misprinted directions, complications such as irritation or sensitivity could result, so consumers should not use the product and should instead return it to their retailer for a refund. As with any product, if a consumer feels they are having any type of reaction or irritation, they should consultant their physician. This recall affects only the Dream Blonde Bleach and Lightening care kit in the Dream Blonde range of products.

Any consumers looking for more information should call 888-241-9504.