The disease-causing bacteria were found in the product during a recent inspection. The FDA is warning consumers to not use any Clarcon products and to throw away these products.
The FDA said 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.
Officials said a recent inspection of the Clarcon facility was particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases.
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
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:
--Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/DownloadForms/default.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088
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