US Marshals seize sanitizer for bacteria problems
Sun Aug 2,
5:37 am ET
The FDA also
warned the public Saturday not to use any Clarcon products because they contain
harmful bacteria and are promoted as antimicrobial agents that claim to treat
open wounds, damaged skin, and protect against various infectious diseases. No cases have been reported
to the FDA.
Clarcon voluntarily recalled the affected products, marketed
under several different brand names, in June 2009, following an FDA inspection
that revealed high levels of potentially disease-causing bacteria in the
products.
The inspection also uncovered serious deviations from the
FDA's regulations, including poor practices that permitted the contamination.
The FDA's seizure of these products, along with their ingredients, occurred
after Clarcon did not agree to promptly destroy them. 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.
Clarcon produced and distributed over 800,000 bottles of
these products in multiple regions of the country since 2007. Consumers should
not use any Clarcon products and should dispose of them in their household
trash.
Analyses of several samples of the topical antimicrobial
skin sanitizer and skin protectant products revealed high levels of various
bacteria. Some of these bacteria can cause opportunistic
infections of the skin and underlying tissues. Such infections may
need medical or surgical attention and may result in permanent damage, the FDA
said.