FDA: recall of Clarcon skin protectants & sanitizers
"FDA NEWS RELEASE
For Immediate Release: June 8, 2009
Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey at fda. hhs. gov (without the spaces)
Consumer Inquiries: 888-INFO-FDA
FDA Warns Consumers Not to Use Skin Products Made by Clarcon Due to Bacterial Contamination Risk Products marketed under various names
The U.S. Food and Drug Administration announced today that Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection. The FDA is warning consumers to not use any Clarcon products.
Consumers should not use any Clarcon products and should throw these products away in household refuse. Analyses of several samples of over-the-counter topical antimicrobial skin sanitizer and skin 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. Examples of products that should be discarded include:
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
Findings from the FDA’s recent inspection of the Clarcon facility are 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 current Good Manufacturing Practice requirements.
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 either online, by regular mail, fax or phone.
--Online --Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 --Fax: 800-FDA-0178 --Phone: 800-FDA-1088"
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