U.S. Marshals seize drugs from Caraco Pharmaceutical Labs

6/26/2009

ROCKVILLE, Md. U.S. Marshals seized drugs made by generic manufacturer Caraco Pharmaceutical Labs Thursday at the company’s Michigian plants in Detroit, Farmington Hills and Wixom, at the request of the Food and Drug Administration.

The FDA said the seizure resulted from violations of the agency’s current Good Manufacturing Practice requirements by the company. Since January, Caraco has voluntarily recalled drugs due to potential manufacturing defects, including formulation errors and oversized tablets. The FDA found unresolved violations of cGMP requirements during an inspection of Caraco’s Detroit plant in May, the company said.

“The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements,” FDA associate commissioner for regulatory affairs Michael Chappell stated.

In a statement on the seizure, Caraco said it had taken corrective actions and was making “continual improvements,” noting that the seizure did not affect products made outside of Michigan.

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