Distribuidora Lagunera del Norte S.A. de C.V. – FDA Warning Letter, Mar 23, 2021

The FDA issued a Warning Letter to Distribuidora Lagunera del Norte S.A. de C.V. on March 23, 2021, following the detention and refusal of "weper Clean Solutions Hand Sanitizer" at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethanol, only contained an average of 28% v/v ethanol, falling below the CDC's recommended 60% minimum and the 1994 Tentative Final Monograph.

This subpotency renders the drug adulterated under section 501(c) of the FD&C Act due to its strength, purity, or quality falling below purported levels. It is also adulterated under section 501(a)(2)(B), indicating a failure of the firm's quality assurance to meet Current Good Manufacturing Practice (CGMP) requirements.

Furthermore, the product is an unapproved new drug, violating section 505(a) of the FD&C Act, as it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It does not conform to the 1994 TFM or temporary FDA policies for hand sanitizers during COVID-19.

The product is also misbranded under sections 502(a), (c), and (ee) of the FD&C Act. Misbranding violations include