FDA WARNING_LETTER - MXL Comercial, SA de CV - July 14, 2020

On November 10, 2020, the FDA issued a Warning Letter to MXL Comercial S.A. de C.V., a human drug manufacturer in Leon, Gto., Mexico. The letter addresses violations concerning their Hand Sanitizer Disinfectant Gel, 70% Ethyl Alcohol, which was detained and refused admission into the U.S.

FDA laboratory testing revealed the product, labeled to contain 70% ethyl alcohol, actually contained 0-37% ethyl alcohol and 11-41% methanol. This constitutes adulteration under section 501(d)(2) of the FD&C Act due to substitution of the active ingredient with methanol, a dangerous chemical. This also indicates a failure of the firm's quality assurance system, violating CGMP requirements (section 501(a)(2)(B)).

Furthermore, the product is an unapproved new drug (section 505(a)) and is misbranded under sections 502(j), (a), (e), and (ee) of the FD&C Act. It is dangerous due to methanol, misleadingly labeled as a "disinfectant" and for its ethyl alcohol content, and fails to declare methanol as an ingredient.

The FDA recommended engaging a qualified CGMP consultant. The firm's drugs are on Import Alert 66-78 since July 24, 2020