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Archive for June, 2009

FDA Warning: ‘High Levels’ Of Disease-Causing Bacteria In Hand Sanitizers

Wednesday, June 10th, 2009

The Food and Drug Administration warned consumers Monday not to use skin products made by Clarcon because of high levels of disease-causing bacteria found during a recent inspection.

Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, issued a voluntary recall of some skin sanitizers and skin protectants marketed under several different brand names, the FDA said in a statement.

Consumers should not use any Clarcon products and should throw them away, the FDA said.

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, according to the agency. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as 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 and Total Skin Care Work.

The FDA said its findings, following a recent inspection of the Clarcon facility, are particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds and damaged skin and protect against various infectious diseases. The inspection uncovered serious deviations from FDA’s Good Manufacturing Practice requirements, the agency said.

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