FDA WARNING_LETTER - Frozen Wheels, LLC - February 01, 2022

The FDA issued a Warning Letter to Mr. Halwani, a registered drug repacker, on December 20, 2021, following the attempted import of "Greenfrog HAND SANITIZER," "Cleansepure," and "Antibacterial Gel, 70% Ethanol Concentration" between April and June 2020. These products were detained and refused admission.

FDA laboratory testing revealed that "Greenfrog HAND SANITIZER," labeled to contain 70% ethyl alcohol, contained 0% ethyl alcohol and 54% methanol. "Cleansepure," also labeled for 70% ethanol, contained 9.6% ethyl alcohol and 58% methanol. "Antibacterial Gel, 70% Ethanol Concentration," labeled for 70% ethyl alcohol, contained <0.25% ethyl alcohol and 63% isopropanol.

These findings indicate the products are adulterated under section 501(d)(2) of the FD&C Act, as active ingredients were wholly or partially substituted with other substances, including dangerous chemicals like methanol. Introduction of such adulterated products into interstate commerce is prohibited under section 301(a) of the FD&C Act. The FDA had previously notified the public about methanol contamination in "Greenfrog HAND SANITIZER" and "Cleansepure" in August and September 2020.

The letter requires a written response within