New York Dietary Supplement Maker recalls Adulterated Supplements
The U.S. District Court of New York has entered a consent decree of permanent injunction against Applied Polymer Systems dba APS Pharmaco (APS) and its president, Nuka Reddy, of Lindenhurst, New York, to prevent the distribution of adulterated dietary supplements. It has been permanently enjoined from operating and must recall all products sold since Jan 1, 2014.According to a complaint filed July 21, APS violated the Federal Food, Drug and Cosmetic Act (FDCA) by manufacturing and distributing adulterated dietary supplements.Under the FDCA, dietary supplement manufacturers are required to ensure that their products meet specifications for identity, purity, strength and composition.The government’s actions resulted from a series of inspections of APS manufacturing facility beginning in 2012 which revealed “significant deviations” from cGMPs (current Good Manufacturing Practices). APS failed to perform identity tests or examinations for certain dietary ingredients before using them in their products. Also, it failed to establish product specifications for the identity, purity, strength and composition of finished batches of dietary supplements.
The consent decree entails the dietary supplement manufacturer to cease all operations and if they wish to resume manufacturing dietary supplements in the future, the FDA must ensure that APS’ manufacturing practices have come into compliance with the law.