Laavo Clean, S.A. de C.V. – FDA Warning Letter, Aug 15, 2023

The FDA issued a Warning Letter to Laavo Clean, S.A. de C.V., a registered human drug manufacturer in Mexico, after its Instant Hand Sanitizer LaavoClean without Alcohol and Instant Hand Sanitizer LaavoClean KIDS without Alcohol products were detained and refused admission at the U.S. border. FDA laboratory testing revealed these consumer antiseptic hand rub products were adulterated under section 501(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the products' strength, purity, or quality differed from what was represented. The active ingredient, benzalkonium chloride (BZK), was found at levels (0.15% for LaavoClean KIDS, and 0.15% and 0.12% for LaavoClean) that deviated from the labeled 0.13% and United States Pharmacopeia (USP) limits, indicating both superpotency and subpotency. Consequently, all drugs from the firm were placed on Import Alert 66-78, and FDA publicly notified consumers of the issues. The firm must investigate the causes of these violations, prevent recurrence, and provide a written response within 15 working days detailing corrective actions. If the firm intends to manufacture drugs for the U.S. market in the future, a Regulatory Meeting is required.