Officials Seize Bacteria-Contaminated Skin Sanitizer Products

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Bacteria-contaminated skin sanitizers and skin protectants at Clarcon Biological Chemistry Laboratory’s Roy, Utah facility have been seized by U.S. Marshals at the request of the FDA. This seizure of skin products followed to earlier Clarcon recall.

The Clarcon products seized may actually cause infections due to the harmful bacteria contamination rather than protect the skin from such bacteria. The products are promoted as antimicrobial. No cases of infection have been reported to the FDA.

The Clarcon products are marketed under several different brand names. Clarcon had initiated a voluntary recall of the affected products in June 2009 following an FDA inspection that revealed high levels of potentially disease-causing bacteria in the products.

The FDA’s seizure of these products, along with their ingredients and any in-process or bulk materials, occurred after Clarcon did not agree to promptly destroy them. The FDA wishes to protect the public by preventing these products from entering the marketplace.

Analyses of several samples of the topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria. 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.

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Clarcon has produced and distributed over 800,000 bottles of these skin sanitizer/protectant products in multiple regions of the country since 2007. Consumers should not use any Clarcon products and should dispose of them in their household trash.

Examples of these Clarcon products 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

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

-- FDA 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

Source
FDA News Release

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