FDA WARNING_LETTER - Grupo Yacana Mexico, S.A.S. de C.V. - January 26, 2021

The FDA issued a Warning Letter to Grupo Yacana Mexico, S.A.S. de C.V. after testing their YACANA Alcohol Antiseptic 70% and YACANA Isopropyl Alcohol Antiseptic 70% hand rub products, which were detained at the U.S. border. Laboratory analysis revealed significant adulteration and misbranding. The YACANA Alcohol Antiseptic 70% product was found to contain methanol (a toxic substance) instead of ethyl alcohol, and the YACANA Isopropyl Alcohol Antiseptic 70% product contained ethanol instead of isopropyl alcohol, and was subpotent (61% IPA instead of 70%). These findings demonstrate a failure in the firm's quality assurance system, violating CGMP requirements under 21 U.S.C. 351(a)(2)(B), 351(c), and 351(d)(2).

Furthermore, both products are considered unapproved new drugs, violating 21 U.S.C. 355(a), as they are not generally recognized as safe and effective and do not conform to applicable monographs or temporary COVID-19 policies. They are also misbranded under 21 U.S.C. 352(a), (e), (j), and (ee) due to false/misleading labeling, failure to list methanol as an ingredient, being dangerous to health, and non-compliance with nonprescription drug marketing requirements.

The FDA recommended engaging a CGMP consultant and requested detailed investigations into the substitutions, subpotency, raw materials, distribution records, and batch records. The firm had already initiated a voluntary recall, and all its products are on Import Alert 66-78, prohibiting admission without physical examination until compliance is established. A response detailing corrective actions is required within 15 working days.