Skin Care Product Recall: Risk of Bacterial Contamination

The FDA is warning consumers not to use any Clarcon skin products, including Citrushield, Dermassentials, Skin Shield and Total Skin Care, as they may be contaminated with bacteria that could cause serious skin infections.

The skin care product recall involves over-the-counter topical antimicrobial skin sanitizers and hand protectant products made by Clarcon Biological Chemistry Laboratory, Inc., which have been found to contain “high levels of disease-causing bacteria,” according to the FDA. This could cause infections of the skin or underlying tissue, potentially requiring surgery or resulting in permanent damage.

The Clarcon skin care product problems were discovered by the FDA when several samples from the manufacturing plant were analyzed during an inspection that revealed serious deviations from the FDA’s current Good Manufacturing Practice requirements.

“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 againt various infectious diseases,” said that FDA in a statement issued June 8, 2009.

All products manufactured by Clarcon are involved in the recall, 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

The recalled skin products were designed primarily for industrial use. Citrushield is a skin protection product marketed toward industrial users who handle harsh chemicals, such as mechanics and janitors. Skin Shield products are usually sold on janitor and restaurant supply websites.

Clarcon Biological Chemistry Laboratory, Inc., based in Roy, Utah, is a relatively new company, with the Citrushield and Dermassentials products released this year. Dermassentials was being sold under the BioGoods Company label.

The FDA has recommended that consumers discard any Clarcon skin products and report any adverse reactions to the FDA’s MedWatch Adverse Event Reporting program. However, product liability lawyers recommend that if any serious skin reactions were caused by the Clarcon skin sanitizers or hand protectants, any remaining product should be preserved in a manner designed to avoid future use until appropriate testing can be completed.