Skin sanitizers found to be contaminated, FDA warns

| June 10, 2009

 warning-signDo not use any skin products made by Clarcon, the U.S. Food and Drug Administration (FDA) warns.

Some skin sanitizers and skin protectants produced by Clarcon Biologial Chemistry Laboratory, Inc. of Roy, Utah have been found to contain “high levels of disease-causing bacteria”, the FDA said.

“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.

“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 FDA said.

The recalled products are marketed under a number of brand names.

Among the products that the FDA says should be immediately discarded are:

  • 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

Clarcon is voluntarily recalling the products identified as contaminated by the FDA.

To learn more:

  • Read the full FDA health advisory below.
  • Visit the FDA’s Web site which has pictures of the recalled product labels.

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:

    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

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.

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Category: Drugs & Medicines, Product Recall, Skin, Hair & Nail

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