FDA WARNING_LETTER - Grupo Asimex de Mexico SA de CV - November 06, 2020

The FDA issued a Warning Letter to Grupo Asimex de Mexico S.A. de C.V. on November 6, 2020, following the detention and refusal of their ANTISEPTIC Hand Sanitizer Florance Morris at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethanol, actually contained significantly lower ethanol levels (19% and 27%) and undeclared methanol (2.1% and 38%).

This constitutes adulteration under 21 U.S.C. 351(d)(2) due to substitution of ethanol with dangerous methanol, and under 21 U.S.C. 351(a)(2)(B) for demonstrating a non-functioning quality assurance system not in accordance with Current Good Manufacturing Practice (CGMP) requirements. Methanol is toxic and can cause severe health issues, including blindness and death.

Furthermore, the product is an unapproved new drug, violating 21 U.S.C. 355(a), as it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It also fails to conform to the 1994 Tentative Final Monograph for OTC topical antiseptics or FDA's temporary COVID-19 hand sanitizer policies.

The product is also misbranded under 21 U.S.C. 3