FDA Issues Warning for Clarcon Skin Products

Hi Levels of Infectious Bacteria Found in Some Products

The U.S. Food and Drug Administration announced today 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.

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.

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.

Some of the bacteria identified 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

The inspection uncovered serious deviations from FDA's current Good Manufacturing Practice requirements.

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Published on Jun-9-09