Tuesday, August 4, 2009

Risk of bacterial contamination has led the Food and Drug Administration (FDA) to warn consumers to not use any products made by Clarcon Biological Ch

2. 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 WorkWhat should consumers do with these products if they 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.No action is required of local health departments at this time for either this recall or this warning. If any requests for assistance are received from the FDA, the Food and Drug Safety Program will contact you. For additional information regarding these issues, please click on the weblinks below.

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