FDA WARNING_LETTER - MYM Hidrominerales S.A. de C.V. - April 09, 2021

The FDA issued a Warning Letter to MYM Hidrominerales, S. A. de C.V., a registered human drug manufacturer, following the detention and refusal of admission of their "Protz real protection ANTIBACTERIAL HAND SANITIZER" at the U.S. border. FDA laboratory testing revealed the product, labeled to contain 70% ethyl alcohol, actually contained an average of 0.05% ethanol and 79% methanol.

This constitutes adulteration under section 501(d)(2) of the FD&C Act due to the substitution of ethanol with toxic methanol, and under 501(a)(2)(B) for demonstrating a non-functioning quality assurance system. The product is also an unapproved new drug (505(a)) and misbranded (502(j), (a), (e)(1)(A), (f)(2), (x), (ee)) because it is dangerous, falsely labeled, lacks required warnings, omits a complete domestic contact, and does not comply with nonprescription drug marketing requirements.

The FDA placed all the firm's drugs on Import Alert 66-78. The company must provide a detailed investigation into the methanol substitution, a list of all raw materials and suppliers for hand sanitizers, a list of all batches shipped to the U.S. with reconciliation, and complete batch records. The FDA strongly recommends engaging a