FDA WARNING_LETTER - Ismar Soluciones Dinámicas S de RL de CV - August 05, 2020

The FDA issued a Warning Letter to Ismar Soluciones Dinámicas S de RL de CV, a human drug manufacturer in Mexico, after their OZÓ HAND SANITIZER was detained at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethyl alcohol, actually contained only 1% ethanol and 62% methanol. This substitution with methanol, a dangerous chemical, renders the product adulterated under 21 U.S.C. 351(d)(2) and indicates a failure of quality assurance per CGMP requirements (21 U.S.C. 351(a)(2)(B)).

Furthermore, OZÓ HAND SANITIZER is an unapproved new drug, violating 21 U.S.C. 355(a) and 331(d), as it is not generally recognized as safe and effective (GRASE) and does not conform to the 1994 Tentative Final Monograph or meet conditions for marketing under 21 U.S.C. 355h (Section 505G). The product's ethanol concentration is below the TFM, and methanol is neither an acceptable active nor inactive ingredient (21 CFR 330.1(e)).

The product is also extensively misbranded under 21 U.S.C. 352(j), (a), (e), (x), and (ee) because it is dangerous to health, its labeling is false/misleading regarding active ingredients, it fails to list methanol, lacks a domestic adverse event reporting contact, and does not comply with 505G requirements. The FDA recommends engaging a CGMP consultant if the firm intends to resume U.S. market manufacturing. All the firm's drugs are on Import Alert 66-78. The firm is required to respond within 15 working days with a detailed investigation, raw material lists, batch records, and reconciliation for all hand sanitizers shipped to the U.S.