Eskbiochem Warning Letter News – The U.S. Food and Drug Administration (FDA) has issued a warning letter to Eskbiochem S.A. de C.V. (Eskbiochem) related to undeclared methanol (wood alcohol) found in hand sanitizer products.
To date, Resource Recovery & Trading, 4e Brands, LIQ-E S.A. de C.V., among others, have initiated recalls for their hand sanitizer products. The U.S. Food and Drug Administration’s (FDA) last recall update was on July 2, 2020.
Eskbiochem Warning Letter Information
On July 23, 2020, the FDA, via the Center for Drug Evaluation and Research (CDER), issued a warning letter to Eskbiochem regarding the ongoing recalls of hand sanitizer products. Warnings regarding Eskbiochem have previously come on June 19, 2020 and June 29, 2020, as well as recalls via additional distributors of Eskbiochem hand sanitizer products.
The FDA writes that “ClearCare Nogerm ADVANCED HAND SANITIZER” and “LAVAR GEL HAND SANITIZER” were detained and refused admission at the border. Tests were performed on these products and, per the FDA’s warning letter, officials found the hand sanitizer products were:
…adulterated within the meaning of section 501(d)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(d)(2), in that a substance was substituted wholly or in part therefor. In addition, these products are adulterated within the meaning of section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)), in that the substitution demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.
Methanol has been found in the above, as well as many other hand sanitizer products and is not an acceptable ingredient for hand sanitizers due to its toxic effects.
In accordance with the warning letter to Eskbiochem, the FDA has given the company fifteen (15) working days to respond with a viable plan of action.
About Methanol Poisoning
Per the FDA, methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although people using these products on their hands are at risk for methanol poisoning, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate medical treatment for potential reversal of toxic effects of methanol poisoning.
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