FDA WARNING_LETTER - Liq-E S.A. De C.V. - November 19, 2020

On November 19, 2020, the FDA issued a Warning Letter to Liq-E S.A. de C.V., a registered human drug manufacturer in Mexico, following the detention and refusal of their Optimus Lubricants Instant Hand Sanitizer at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethanol, actually contained an average of 51% ethanol and 18% 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. Methanol is dangerous, causing dermatitis, systemic toxicity, and potentially blindness or death.

The product is also an unapproved new drug under section 505(a) and misbranded under sections 502(j), (a), (e), (i), (x), and (ee) of the FD&C Act. Violations include: being dangerous to health (502(j)), false and misleading labeling regarding ethanol content and undeclared methanol (502(a)), failure to list methanol as an ingredient (502(e)), misleading container resembling a water bottle (502(i)), failure to disclose a domestic adverse event contact (502(x)), and non-