FDA warns consumers not to use skin products made by Clarcon (PR)

FDA NEWS RELEASE

For Immediate Release: June 8, 2009

Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov
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:

  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.

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

Consumers Warned Not to Use Clarcon Skin Products


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.
 

From FDA.gov