Clarcon Hand Sanitizers and Protectants - Clarcon Labs - Utah

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http://www.foxnews.com/story/0,2933,536168,00.html

U.S. Marshals Seize Sanitizer Made by Utah Company
Sunday , August 02, 2009


Officers with the U.S. Marshals Service have seized all skin sanitizers and skin protectants, including ingredients and components, at Clarcon Biological Chemistry Laboratory's facility in Roy, Utah, the Food and Drug Administration said.

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.

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http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm164845.htm

Consumers Warned Not to Use Clarcon Skin Products
Search Consumer Updates
       
Risk of bacterial contamination has led the Food and Drug Administration (FDA) to warn consumers to not use any products made by Clarcon Biological Chemistry Laboratory Inc.

The Roy, Utah, firm voluntarily recalled some skin sanitizers and skin protectants sold under a variety of brand names after a recent FDA inspection found that the products contained high levels of disease-causing bacteria.

 

What products are consumers being warned not to use?

Consumers should not use any Clarcon products. Examples of these products include

• 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

 

What should consumers do with these products if the have them?

Stop using them immediately and throw them away in household refuse.

 

What specific concerns does FDA have about these products?

Analyses of several samples of over-the-counter topical antimicrobial skin sanitizer and hand protectant products revealed high levels of various bacteria, including some associated with unsanitary conditions.

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.

FDA finds the inspection results particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases.

The inspection uncovered serious deviations from FDA’s requirements.

 

How can consumers report adverse events resulting from these products?

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program.

 

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

Date Posted: June 8, 2009

     

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http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm165169.htm