FDA WARNING_LETTER - Notarika, S.A. de C.V. - August 11, 2020

The FDA issued a Warning Letter to Eléctrica de México (Notarika, S.A. de C.V.) on October 7, 2021, following the detention and refusal of their Greenfrog HAND SANITIZER at the U.S. border. The firm was registered as a human drug manufacturer.

FDA laboratory testing revealed the Greenfrog HAND SANITIZER, labeled to contain 70% ethanol, actually contained 0% ethanol and 54% methanol. This constitutes adulteration under section 501(d)(2) of the FD&C Act due to substitution of the active ingredient with a dangerous chemical, and under 501(a)(2)(B) for demonstrating a non-functioning quality assurance system. Methanol is toxic and not an acceptable ingredient.

Furthermore, the product is an unapproved new drug under section 505(a) and misbranded under sections 502(j), (a), (e), (c), (f)(2), (i), and (ee). Misbranding violations include being dangerous to health, false labeling regarding active ingredients, failure to list all ingredients, absence of a "Drug Facts" panel, missing warnings, misleading packaging resembling a water bottle, and non-compliance with section 505G for nonprescription drugs.

The FDA recommended engaging a qualified CGMP consultant to evaluate operations and assist with compliance. All drugs manufactured by