Clarcon Skin Sanitizer Bust

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In trouble again. What’s wrong with this company? The FDA should be a permanent fixture at their plant or perhaps close the facility.

This past June, the FDA inspected Clarcon Biological Chemistry Laboratory in Roy, Utah, a company that makes skin sanitizer and skin protectant. The agency found conditions less than sanitary and there was nothing protective about their products.

High levels of potentially disease-causing bacteria was found in brands that claimed to contain antimicrobial agents. These agents are ‘supposed’ to aid damaged skin, open wounds, and protect against miscellaneous infectious diseases.

As a result of the critical inspection, Clarcon voluntarily recalled the affected products and was mandated by the FDA to clean up and destroy the contaminated items.

Apparently Clarcon decided to ignore the agency’s warning. August 1, the FDA released a statement that U.S. Marshals had seized all skin sanitizers and skin protectants, including ingredients and components at the Utah site. The agency also advised consumers to cease using any Clarcon products and dispose of them.

The inspection also revealed significant deviations from the FDA’s Current Good Manufacturing Practice regulations, including oversights that caused the initial contamination. Sample analyses of several topical antimicrobial sanitizer and protectant products had high levels of various bacteria—some which could cause opportunistic infections of the skin and underlying tissues. Medical or surgical attention might be required and permanent damage could occur.

The agency 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. We will remain vigilant in our efforts to protect consumers from defective products,” stated 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 in multiple regions of the country since 2007. The following are items that should be discarded now:

Citrushield Lotion
Dermasentials DermaBarrier
Dermasentials 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

Contact the FDA’s MedWatch Adverse Event Reporting program at:
Phone: 800-FDA-1088
Fax: 800-FDA-0178

Hopefully, this is Clarcon’s last reprieve.