ALVA-AMCO Pharmacal Companies, LLC Warning Letter Details

Summary

ALVA-AMCO Pharmacal Companies, LLC was cited for manufacturing and distributing "Nauzene Kids," an unapproved new drug product intended to treat nausea and upset stomachs in children, in violation of Federal Food, Drug, and Cosmetic Act sections 301(d) and 505(a). The product lacked required FDA approval and made therapeutic claims ("Relief of Nausea," "relieves nausea and upset tummies") that established it as a drug without an approved new drug application. The FDA emphasized that the violation was particularly concerning because the product was directed toward young children and was manufactured by Denison Pharmaceuticals, LLC, which had recently been cited for significant current good manufacturing practice (CGMP) violations in a separate warning letter.