According to a report today in the Salt Lake Tribune, Clarcon Biological Chemistry Laboratory in Roy was raided last Friday by U.S. Marshals. The raid comes on the heels of an FDA inspection which revealed that the company’s production process were not in conformity with FDA’s Current Good Practice Manufacturing regulations.
Clarcon makes skin care products marketed as antimicrobial agents designed to treat open wounds, areas of damaged skin and ward of certain infectious diseases. But the inspection indicates that the products themselves contained bacteria causing contaminants which can cause infections and, potentially, permanent damage. The company issued a voluntary recall in June but then apparently did not destroy the contaminated products and raw ingredients which led to the raid in which an estimated 2.7 million worth of goods was seized.
The text of the FDA warning is:
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.
Date Posted: June 8, 2009
The future of the company is unclear at this time; the company is not commenting on the situation and did not answer calls yesterday. And today I received an error message when I tried to visit the Carcon labs website (www.clarconlabs.net).
Bret Hanna of Wrona DuBois in Utah, focuses exclusively on litigating plaintiffs’ medical malpractice and catastrophic personal injury cases. He has represented clients in state and federal courts, in mediations, and in administrative proceedings in Michigan and Utah since 1991.
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