FDA WARNING_LETTER - Asiaticon, SA de CV - November 03, 2020

The FDA issued a Warning Letter to Asiaticon S.A. de C.V. on October 29, 2020, following the detention and refusal of admission of their V-KLEAN HAND SANITIZER GEL product at the U.S. border. FDA laboratory testing revealed the product, labeled to contain 70% ethyl alcohol, actually contained an average of 33% ethanol and 38% methanol.

This substitution of ethanol with toxic methanol renders the product adulterated under section 501(d)(2) of the FD&C Act, and demonstrates a failure of quality assurance under section 501(a)(2)(B). Methanol is dangerous, causing potential dermatitis, systemic toxicity, blindness, nervous system damage, or death. The product is also an unapproved new drug, violating section 505(a), and is misbranded under sections 502(j), (a), (e), and (ee) due to being dangerous, having false labeling regarding active ingredients, and failing to declare methanol.

Asiaticon S.A. de C.V. was advised to recall all hand sanitizer products from the U.S. market, which they initiated on August 25, 2020. The FDA recommends engaging a qualified CGMP consultant to evaluate operations and assist with compliance. The firm must respond within 15 working days with a detailed investigation