Clarcon Skin Sanitizer Seized Due to Risk of Bacterial Infection

At the request of the FDA, U.S. Marshals raided a skin care products company last week, rounding up skin sanitizers and skin protection products that might contain harmful bacterial contamination.

The raid occurred at Clarcon Biological Chemical Laboratory Inc.’s Roy, Utah facility. The FDA said the company failed to destroy a number of products designed to protect and sanitize users’ skin after finding that they were contaminated with harmful bacteria. The skin care products were part of a Clarcon skin sanitizer recall announced in early June.

The contaminated Clarcon skin care products involved topical antimicrobial skin sanitizers and hand protectant products that were marketed for large-scale industrial and commercial use. They were used in restaurants and hospitals, as well as by mechanics, janitorial services, and other companies that used large amounts of skin sanitizers.

FDA inspections found that many of the products contained high levels of disease-causing bacteria, which were of particular concern since the products were often marketed to be used to protect hands with open wounds and cuts.

According to the FDA, some of the bacteria found in samples of Clarcon products can cause opportunistic skin infections that could result in permanent damage and require medical or surgical attention.

U.S. Marshals seized all skin sanitizers and protectants, ingredients and components at the Clarcon facility. The FDA said the raid was necessary to prevent the products from getting out and endangering the public. While Clarcon issued a voluntary recall, FDA said that it did not comply with orders to destroy the potentially contaminated products.

The FDA has urged consumers, retailers and business owners to discard any skin sanitizers and skin protectant products by Clarcon, including:

• Citrushield Lotion
• Dermassentials 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

FDA officials said that inspections of the facility found “serious deviations” from the FDA’s Good Manufacturing Practices, some of which could allow dangerous bacterial contamination. The FDA estimated that Clarcon has produced and distributed more than 800,000 bottles of potentially contaminated products across the country since 2007.