9 June 2009

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FDA warns consumers on bacterial contamination risk in skin products

The FDA is warning consumers to not use any Clarcon products due to bacterial contamination.

The U.S. Food and Drug Administration (FDA) announced yesterday (June 08, 2009) that Clarcon Biological Chemistry Laboratory Inc., a skin care manufacturer headquartered in 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 products.

The contamination was revealed during a recent FDA’s inspection of the Clarcon facility. “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”, the agency reveals. The inspection uncovered serious deviations from FDA’s current Good Manufacturing Practice requirements.

The FDA adds these findings 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 these bacteria can cause opportunistic infections of the skin and underlying tissues,FDA adds. Such infections may need medical or surgical attention, and may result in permanent damage.

The FDA is warning consumers to not use any Clarcon products and to throw these products away in household refuse.


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