FDA WARNING_LETTER - Industrias Cklass S. de R.L. de C.V. - June 22, 2022

The FDA issued a Warning Letter to Industrias Cklass S. de R.L. de C.V. on June 22, 2022, following the detention and refusal of admission of their "cklass Hand Sanitizer WITH ALOE ENRICHED WITH MOISTURIZING AND EMOLLIENT AGENTS" product at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethanol, actually contained an average of 19% ethanol and 48% methanol.

This constitutes adulteration under section 501(d)(2) of the FD&C Act due to the substitution of ethanol with dangerous methanol, and under 501(a)(2)(B) due to 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 is dangerous, falsely labeled regarding ethanol content, fails to declare methanol, and does not comply with nonprescription drug marketing requirements.

The FDA attempted to contact the firm, its U.S. agent, and consignee regarding a recall but received no response. The firm's drugs were placed on Import Alert 66-78 on September 11, 2020. The FDA recommends engaging a qualified CGMP consultant. The firm must respond within 15