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Wednesday, June 10, 2009

FDA Inspection Lead to Recall of Clarcon Hand Sanitizer and Lotion Products

Given the fact that the products referenced are non-flammable, the news that a recent inspection by the FDA of Clarcon Biological Chemistry Lab Inc. has caused the company to recall its products has caused a firestorm of comment and mentions across the media.

We actually spoke with Siobhan DeLancey at the FDA's Office of Public Affairs this morning, and Ms. DeLancey confirmed that the inspection of Clarcon's manufacturing facility "uncovered serious deviations from FDA’s current Good Manufacturing Practice requirements.

Select samples of different Clarcon products inspected onsite at the manufacturing facility were found to have low-level readings of bacterial contamination.

Because Clarcon, in its infinite wisdom (that's a sarcastic remark) does not publish the ingredients of its various products on its website, the only source of information specific to the ingredients are provided via the FDA-provided link in this posting, which are merely photocopies of photos that FDA inspectors took onsite at the manufacturing plant.

That said, and despite one FDA observation that all of the company's products appear to be the same formula, and just merely marketed using different names for different uses, upon close inspection of the photocopies of the labels, the ingredients themselves in the products do vary, and all appear to be typical to those found in many other consumer products, from soaps to non-alcohol hand sanitizers, to lotions.

This leads most educated professionals to conclude that the ingredients themselves are not the root of the nominal bacteria levels discovered in the FDA sampling, but that Clarcon's manufacturing facility itself does not conform to 'clean room' standards that are observed by most credible manufacturers of these types of products.

The fact is, almost any type of product, whether it be an antiseptic, a germ killer, an industrial cleaning product, or even something as potent as chemotherapy, can become 'tainted' in a non-clean manufacturing environment.

These are the Clarcon brands that are being re-called. Apparently none are sold via retail outlets, and only sold via distributors:

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

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