Marshals Raid Clarcon Products Labs

The FDA has issued a warning regarding Clarcon Products: the warning states that the seizure was made because they contain harmful bacteria and yet are promoted as antimicrobial agents that claim to treat wounds and damaged skin, and also to protect against various infectious diseases.

Clarcon products were voluntarily recalled in June 2009, following an FDA inspection that revealed high levels of potentially disease-causing bacteria in the products. The products were marketed under several different brand names. However, the "raid" appears to have been made, according tot he FDA, because Clarcon did not agree to promptly destroy the remaining products and components.

Additionally, an FDA inspection after the June recall found that the company was deviating from the FDA’s Current Good Manufacturing Practice regulations. It was these poor practices that caused the contamination of Clarcon products.

The FDA warning regarding Clarcon products is quite alarming, to be honest, but is probably written to be that way on purpose. The FDA notes that the bacteria involved can cause infections of the skin and underlying tissues, such that need surgical attention may be requird.

Examples of Clarcon products that should be discarded are, as listed at the FDA site, 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

Health care professionals and consumers may report adverse events with the use of Clarcon products to the FDA's MedWatch Adverse Event Reporting program either online, or 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