FDA WARNING_LETTER - Albek de Mexico S.A. de C.V. - March 11, 2021

The FDA issued a Warning Letter to Albek de Mexico S.A. de C.V. following laboratory testing of their NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER, which was detained at the U.S. border. Testing revealed the product, labeled to contain 70% ethanol, actually contained significantly lower ethanol concentrations (37-55%) and undeclared, toxic methanol (10-29%).

These findings led to multiple violations: The product is adulterated under section 501(d)(2) of the FD&C Act due to active ingredient substitution (methanol for ethanol) and under 501(a)(2)(B) for demonstrating a failure in quality assurance and CGMP requirements. It is also an unapproved new drug under section 505(a) and 301(d) because it is not generally recognized as safe and effective (GRASE), does not conform to the 1994 Tentative Final Monograph, and fails to meet conditions for marketing under section 505G(a)(3). Furthermore, methanol is not a safe or suitable inactive ingredient per 21 CFR 330.1(e).

The product is misbranded under sections 502(j) (dangerous to health), 502(a) (false/misleading labeling), 502(e)(1)(A) (failure to list ingredients), and 502(ee) (non-compliance with 505G). FDA recommended a voluntary recall, placed all the firm's drugs on Import Alert 66-78, and strongly advised engaging a CGMP consultant. The firm must respond within 15 working days with corrective actions.