FDA: Tri-Med selling unapproved, adulterated drugs
SILVER SPRING, Md. U.S. Marshals earlier this month seized articles of prescription and over-the-counter drug products from Tri-Med Labs in Somerset, N.J., at the request of the Food and Drug Administration, the agency announced Wednesday. The seizure warrant, issued by the U.S. District Court for the District of New Jersey and unsealed this week, shows the drugs are unapproved and adulterated new drugs.
“The FDA is taking this action because Tri-Med has refused to take these unapproved products off the market after it received warning letters and regulatory meetings,” stated Dara Corrigan, the FDA’s associate commissioner for regulatory affairs. “This action shows the FDA’s commitment to protecting the public health from the dangers of unapproved or adulterated drug products.”
The FDA has been on the case approaching 13 years — FDA inspections of Tri-Med since 1997 revealed Tri-Med continued to manufacture and distribute unapproved, misbranded and adulterated drugs with significant Good Manufacturing Practices violations.