Harmful skin sanitizers seized in U.S.
www.chinaview.cn 2009-08-02 14:33:29   Print

    LOS ANGELES, Aug. 1 (Xinhua) -- All skin sanitizers and skin protectants made by a Utah company have been seized by the U.S. Marshals Service because they were believed to contain harmful bacteria, the Food and Drug Administration (FDA) announced on Saturday.

    Analyses of several samples showed that the products, made at Clarcon Biological Chemistry Laboratory's facility in Roy, Utah, contained high levels of various bacteria that can cause opportunistic infections of the skin and underlying tissues, the FDA said.

    Such infections may need medical or surgical attention and may result in permanent damage, but no cases have been reported, according to the FDA.

    Clarcon produced and distributed over 800,000 bottles of these products in multiple regions of the country since 2007.

    The FDA also warned the public not to use any Clarcon products which are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases.

    Following an FDA inspection that revealed high levels of potentially disease-causing bacteria in the products, Clarcon voluntarily recalled the affected products, marketed under several different brand names, in June 2009.

    But later inspection uncovered serious deviations from the FDA's regulations, including poor practices that permitted the contamination, the FDA said. The seizure of these products, along with their ingredients, occurred after Clarcon did not agree to promptly destroy them, said the FDA.

    The FDA said it is protecting the public by preventing these products from entering the marketplace.

    "The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our current good manufacturing practice requirements," said Deborah M. Autor, director of the FDA's Center for Drug Evaluation and Research Office of Compliance.

Editor: Lin Zhi
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