US Marshals have seized prescription and over-the-counter drug products from Tri-Med Laboratories as they were found to be unapproved and adulterated.
According to the US Food and Drug Administration (FDA), who asked the US Marshals to act, the drug products manufactured and distributed by Tri-Med were found to be unapproved new drugs under the Federal Food, Drug and Cosmetic Act, and were not proven to be safe and effective for their indicated use.
In addition, the seized products were adulterated as they were manufactured under conditions that were not in compliance with current good manufacturing practice (cGMP).
Dara Corrigan, the FDA associate commissioner for regulatory affairs, said that the FDA took this action because Tri-Med had refused to take its unapproved products off the market after warning letters and regulatory meetings.
FDA inspections of Tri-Med since 1997 have shown that the company continued to manufacture distribute unapproved, misbranded and adulterated drugs with significant cGMP violations.