FDA Seizes Skin Sanitizers Over Bacterial Contamination

The Food and Drug Administration today announced it has seized skin sanitizers made by Clarcon Biological Chemistry Laboratory because the products contain potentially harmful bacteria.

The products, sold under several different brand names, are marketed to treat open wounds, damaged skin, and to protect against infectious diseases. Clarcon recalled the skin sanitizers in June 2009 after FDA inspections of the company’s manufacturing facility in Roy, Utah detected high levels of bacteria and violations of the FDA’s Current Good Manufacturing Practice regulations that allowed the contamination.

The FDA has now taken the extra step of seizing the recalled products and all ingredients and components used to make them in an effort to further protect consumers from bacteria. The bacteria detected in the Clarcon products can result in opportunistic infections of the skin and underlying tissues, which in some cases may require surgery to treat and can result in permanent damage, the FDA said.

“The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our current good manufacturing practice requirements,” said Deborah M. Autor, director of the FDA’s Center for Drug Evaluation and Research Office of Compliance. “We will remain vigilant in our efforts to protect consumers from defective products.”

More than 800,000 bottles of the skin sanitizers were made and distributed throughout the United States since 2007, the FDA said. The following brands of products were recalled and now have been seized by the FDA:

• 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

Consumers who have the Clarcon products in their possession are advised not to use them and to throw them in the trash.

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