FDA WARNING_LETTER - Roque Plast S.A. de C.V. - April 09, 2021

The FDA issued a Warning Letter to Roque Plast S.A. de C.V. on April 9, 2021, following the detention and refusal of their "COMMAND BRANDS GEL ANITBAC INSTANT HAND SANITIZER" at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethanol, actually contained only 38% ethanol and 25% methanol, a toxic substance.

This constitutes adulteration under section 501(d)(2) of the FD&C Act due to substitution of the active ingredient and 501(a)(2)(B) for demonstrating a non-functioning quality assurance system. The product is also an unapproved new drug (505(a)) and misbranded (502(j), (a), (e), (ee)) because it's dangerous, falsely labeled regarding ethanol content, fails to declare methanol, and doesn't comply with nonprescription drug marketing requirements.

Roque Plast had previously issued a voluntary recall on August 4, 2020, after a July 31, 2020, teleconference with FDA. The FDA questions the validity of the firm's and third-party lab test results given the direct contradiction.

The FDA requires a detailed investigation into the methanol substitution, a list of all raw materials and suppliers for hand sanitizers, a reconciliation of all batches shipped