Recalls and Warnings

FDA Warns Eskbiochem for Hand Sanitizers That May Contain Toxic Ingredient

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(Date Posted: 7/28/2020)

On July 23, 2020, the FDA issued a warning letter to Eskbiochem SA de CV which found the company's products, including ClearCare Nogerm ADVANCED HAND SANITIZER and LAVAR GEL HAND SANITIZER, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements. Additionally, the products were found to contain methanol, a toxic ingredient.

ClearCare Nogerm ADVANCED HAND SANITIZER is labeled to contain 75% ethanol by volume, but FDA laboratory testing showed that the product contained an average of 39% ethanol and 28% methanol. LAVAR GEL HAND SANITIZER is labeled to contain 70% ethanol by volume, but FDA laboratory testing showed that the product contained 0% ethanol and 83% methanol. Because the active ingredient on each product's label is substituted partially or completely by a different ingredient, the products are adulterated.

Methanol, sometimes called wood alcohol, is poisonous. Methanol exposure through the skin or by ingestion can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. The agency warned that consumers who have been exposed to hand sanitizer containing methanol to "seek immediate treatment, which is critical for potential reversal of toxic effects of methanol poisoning." 

Hand sanitizer containing at least 60% ethyl alcohol (ethanol) is recommended by the CDC for disinfecting hands when soap and water are not available, and is generally considered safe when used as directed. See the CDC's website for more information about using hand sanitizer.

The FDA first warned consumers about the presence of methanol in Eskbiochem products in June. Eskbiochem recalled some of its hand sanitizer products the next week. The agency is advising consumers to stop using products that may contain methanol and to dispose of them.

See related warnings:

Nine Hand Sanitizers May Contain Toxic Ingredient That Can Cause Serious Illness or Death

Hand Sanitizer That May Contain Toxic Ingredient is Recalled

FDA Warns of Five More Hand Sanitizers That May Contain Toxic Ingredient

All Clean Hand Sanitizer Recalled

Seller of Hand Sanitizer "Alternative" Warned for Coronavirus Claims

Forty-Six More Hand Sanitizers May Contain Toxic Ingredient, Ten More Recalled

Two More Hand Sanitizers That May Contain Toxic Ingredient Recalled

Optimus Instant Hand Sanitizer Recalled

For more information, use the link below:

Warning Letter: Eskbiochem SA de CV



For other Recalls and Warnings click HERE.
For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.


 

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