June 9, 2009 -- The FDA is warning consumers not to use any products made by Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, because of the risk of bacterial contamination.
The FDA announced that Clarcon is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because high levels of disease-causing bacteria were found in the products during a recent inspection.
"Consumers should not use any Clarcon products and should throw these products away in household refuse," states an FDA news release.
According to the FDA, 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 those bacteria could cause infection that would require surgical or other medical attention and may result in permanent damage.
The FDA's warning covers all Clarcon products, which include:
- Citrushield Lotion
- Dermasentials DermaBarrier
- Dermasentials 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
The FDA says findings from its 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 also notes that its inspection uncovered serious deviations from FDA's good manufacturing practice requirements.
Bill Markham, co-owner of Clarcon, tells WebMD that the company's products aren't in stores and aren't sold directly to the public, and that "we have never, ever, ever had a side effect, health issue" from the products.
Markham says he has testimonials about how well the products work and that Clarcon has destroyed its products as a precaution and is shifting production to another facility that will have "higher, more intense monitoring."
Markham says Clarcon tested the same batches of products as the FDA and that the FDA did not find contamination in all of the random samples it checked.
"Our findings are not matching their findings," Markham says. "This may be a small, isolated issue ... they only found it in a couple of [bottles]."
Markham says Clarcon and the FDA are investigating the matter and that Clarcon's products will be back in four to five weeks, made at the other facility that the company has contracted with.