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FDA Flags Eskbiochem Hand Sanitizers for Possible Methanol Content

Contact Author Rachel Grabenhofer
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The U.S. Food and Drug Administration (FDA) has issued a warning statement to consumers to not use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico.

According to the FDA statement, this is due to the potential presence of methanol or wood alcohol, a substance that can be toxic when absorbed through the skin or ingested. The FDA has identified the following products manufactured by Eskbiochem:

  • All-Clean Hand Sanitizer (NDC: 74589-002-01)
  • Esk Biochem Hand Sanitizer (NDC: 74589-007-01)
  • CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-04)
  • Lavar 70 Gel Hand Sanitizer (NDC: 74589-006-01)
  • The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10)
  • CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-03)
  • CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-01)
  • CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-01)
  • Saniderm Advanced Hand Sanitizer (NDC: 74589-001-01)

The FDA tested samples of the Lavar Gel and CleanCare No Germ and found the Lavar Gel contained 81% v/v methanol and no ethyl alcohol, and CleanCare No Germ contained 28% v/v methanol. The agency underlines that methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects.

See related: How NOT to Formulate Hand Sanitizers

"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 writes. "Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning."

On June 17, 2020, the FDA contacted Eskbiochem to urge the company remove its hand sanitizer products from the market due to the risks associated with methanol poisoning. To date, the company has not taken action. Therefore the FDA is warning consumers to not use these hand sanitizers and to dispose of them immediately in appropriate hazardous waste containers. 

Methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its
toxic effects.

The FDA also reminded consumers that if soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend using an alcohol-based hand sanitizer that contains at least 60% ethanol. The agency noted it will remain vigilant and will continue to take action when quality issues arise with hand sanitizers.

See related: FDA Warns 1,500 New Sanitizer Makers to Follow the Rules

Additionally, the agency is concerned over false and misleading claims for hand sanitizers, such as those claiming they provide 24-hr protection against viruses including COVID-19. There is no evidence to support these claims. To date, the FDA is not aware of any reports of adverse events associated with these hand sanitizer products.

For more information, visit the FDA website.

 

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