Unapproved and Adulterated Drugs Seized from New Jersey Manufacturer at FDA Request

November 4, 2010 3:09 pm

FDA reports that prescription and over-the-counter drug products were seized from Tri-Med Laboratories, Inc by US Marshals at FDA’s request. The New Jersey manufacturer was producing and distributing unapproved new drugs and adulterated new drugs, according to an FDA news release. FDA stresses that the company’s products are not proven to be safe and effective for their intended use, and that adulterated products were not manufactured under conditions in compliance with current Good Manufacturing Practice to ensure that they meet the identity, quality, and purity standards they claim to possess. Dara Corrigan, the FDA’s associate commissioner for regulatory affairs, explained that the manufacturer received warning letters and other notifications, but did not take the unapproved products off the market. Seizing the unapproved drugs, “shows FDA’s commitment to protecting the public health from the dangers of unapproved or adulterated drug products,” stated Corrigan.