FDA WARNING_LETTER - Limpo Quimicos, SA de CV - September 30, 2021

The FDA issued a Warning Letter to Limpo Quimicos S.A. de C.V. on September 30, 2021, following the detention and refusal of admission of their consumer antiseptic hand rub products, Andy’s Best ADVANCED HAND SANITIZER and NeoNatural gel Hand Sanitizer, at the U.S. border.

FDA laboratory testing revealed significant violations. Andy’s Best ADVANCED HAND SANITIZER, labeled to contain 70% ethyl alcohol, was found to contain an average of 1.0-1.2% ethyl alcohol and 63-66% methanol, a toxic substance. This constitutes adulteration under section 501(d)(2) of the FD&C Act due to substitution. NeoNatural gel Hand Sanitizer, also labeled for 70% ethyl alcohol, contained only an average of 32% ethyl alcohol, violating section 501(c) for subpotency. Both products are adulterated under section 501(a)(2)(B) due to a non-functioning quality assurance system.

Furthermore, both products are unapproved new drugs under section 505(a) and 301(d) of the FD&C Act, as they are not generally recognized as safe and effective (GRASE) and lack FDA approval. They do not conform to the 1994 Tentative Final Monograph