FDA WARNING_LETTER - Sck Zeta Dis Ticaret, Pazarlama Ltd. - July 15, 2021

The FDA issued a Warning Letter to Sck Zeta Diş Ticaret Pazarlama Limited Şirketi, a human drug manufacturer in Istanbul, Turkey, following the detention and refusal of NEUTREVO Instant Hand Sanitizer at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethanol, actually contained an average of 63% ethanol and 6% 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 failure in Current Good Manufacturing Practice (CGMP) quality assurance. Methanol is dangerous, causing dermatitis, systemic toxicity, and potentially blindness or death.

Furthermore, the product is an unapproved new drug, violating section 505(a), as it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It does not conform to the OTC Drug Review's tentative final monograph for hand sanitizers or FDA's temporary COVID-19 policy for hand sanitizers, which do not permit methanol.

The product is also misbranded under multiple sections of the FD&C Act (502(j), (a), (e), (x), (c), (ee)) because it is dangerous, falsely labeled regarding ethanol content and undeclared methanol, fails to list all ingredients and