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FDA Seizes Hand Sanitizers
Aug 3, 2009 | Parker Waichman Alonso LLP
At the U.S. Food and Drug Administration’s (FDA) request, U.S. Marshals have seized all skin sanitizers and skin protectants, including ingredients and components, at Clarcon Biological Chemistry Laboratory’s Roy, Utah facility. The administration is also warning consumers not to use any Clarcon products because they contain harmful bacteria and are promoted as antimicrobial agents that claim to treat open wounds and damaged skin, and claim to protect against various infectious diseases, according to the FDA.
Clarcon has recalled the affected products, which are 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. To date, no cases have been reported to the FDA.
The agency’s inspection also uncovered serious deviations from the FDA’s Current Good Manufacturing Practice regulations, including poor practices that permitted the contamination. The FDA’s seizure of these products, along with their ingredients and any in-process or bulk materials, occurred after Clarcon did not agree to promptly destroy the products.
The FDA said it is working to protect consumers by preventing the recalled Clarcon 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. “We will remain vigilant in our efforts to protect consumers from defective products,” Autor added.
Clarcon produced and distributed over 800,000 bottles of the involved 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 Clarcon’s topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, some of which 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 are:
- 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 FDA is urging health care professionals and consumers to report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm); by regular mail (use postage-paid FDA form 3500 [the form can be accessed at: https://www.accessdata.fda.gov/scripts/medwatch/] and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787); by fax (toll-free at 1-800-FDA-0178), or by telephone (toll-free at 1-800-FDA-1088).
