FDA WARNING_LETTER - Noticias Mexico Hoy Grupo Multimedia, S.A. de C.V. - June 27, 2022

The FDA issued a Warning Letter to Noticias Mexico Hoy Grupo Multimedia SA de CV (FEI 3016821022) on June 27, 2022, following the detention and refusal of their "Medical MARY CLEAN HAND Sanitizers" product at the U.S. border. FDA testing revealed the product, labeled to contain 75% ethanol, actually contained 0.34% ethanol and 78% methanol, a toxic substance.

This constitutes adulteration under 21 U.S.C. 351(d)(2) due to substitution of the active ingredient, and 21 U.S.C. 351(a)(2)(B) for demonstrating a failure in quality assurance and CGMP. The product is also an unapproved new drug (21 U.S.C. 355(a)) and misbranded under 21 U.S.C. 352(j), (a), (e), (x), and (ee) because it is dangerous, falsely labeled, fails to list all ingredients, lacks a domestic contact for adverse events, and does not comply with nonprescription drug marketing requirements.

The FDA previously notified the public of methanol contamination in this product in August 2020, and a distributor agreed to recall, but no market action was taken by the firm or distributor. The FDA recommends engaging