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Law360 (June 22, 2020, 10:20 PM EDT ) The U.S. Food and Drug Administration is cautioning consumers to avoid nine hand sanitizer products manufactured in Mexico that may contain methanol, or wood alcohol, which could be toxic if absorbed through the skin or ingested.
The hand sanitizers are manufactured by Mexico-based Esk Biochem SA de CV, and include All-Clean Hand Sanitizer, Esk Biochem Hand Sanitizer, Lavar 70 Gel Hand Sanitizer, The Good Gel Antibacterial Gel Hand Sanitizer, Saniderm Advanced Hand Sanitizer and several CleanCare hand sanitizers, the FDA said in an advisory issued Friday.
"Consumers who have been exposed to hand sanitizer containing methanol should seek immediate treatment, which is critical for potential reversal of toxic effects of methanol poisoning," the agency said. "Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death."
Although everyone using the products is at risk, young children who've accidentally ingested them are most at risk, the FDA said.
According to the advisory, the FDA tested samples of Lavar Gel and CleanCare No Germ, and the products contained 81% and 28% methanol, respectively. On June 17, the agency contacted Esk Biochem and recommended the company remove its products from the market, but the company hasn't yet done so, the FDA said.
The FDA recommended that consumers immediately stop using the hand sanitizers and dispose of them in "appropriate hazardous waste containers."
"Do not flush or pour these products down the drain," the agency said.
In the advisory, the FDA reiterated concerns about other hand sanitizer companies inaccurately promoting their products as providing prolonged protection against viruses, such as COVID-19. It added that "there is no evidence to support these claims."
The FDA warned the maker of Purell to stop marketing the hand sanitizer as reducing or preventing diseases in January, citing a lack of "adequate and well-controlled studies" backing up those claims. The agency hit Ohio-based Gojo Industries Inc. with the letter Jan. 17.
A few companies have been sued over such claims, including Germ-X maker Vi-Jon Inc. and fellow hand sanitizer company BioDefense Inc. In May, a California federal judge sided with the U.S. Department of Justice in barring BioDefense from marketing its products as protecting against a range of infectious diseases.
And in March, the FDA took steps to boost the production of hand sanitizers, which have flown off store shelves during the pandemic.
The next month, the FDA said in a final rule that it will be seeking more data on the effectiveness and safety of three active ingredients found in over-the-counter hand sanitizers: benzalkonium chloride, ethyl alcohol and isopropyl alcohol. The rule also said that 28 other active ingredients can't be used in those antiseptic rubs anymore.
Esk Biochem representatives didn't immediately return a request for comment late Monday.
--Additional reporting by Adam Lidgett, Mike LaSusa, Mike Curley and Emily Field. Editing by Jay Jackson Jr.
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