August 10th, 2009
The US FDA sought the services of U.S. Marshals to confiscate drug products manufactured by Caraco Pharmaceutical Laboratories Ltd., as well as ingredients held at the facilities in question. They targeted the companies multiple facilities in Detroit, Farmington Hills, and Wixom.
The FDA’s aggressive deployment is a result of Caraco’s negligent in-compliance to meet the FDA’s Good Manufacturing Practice requirements. Their requirements are designed to insure that manufactured drugs are of the utmost quality. The FDA hopes as a result of the confiscation that Caraco will be forced to cease further drug dispensation until the agency is confident that the firm is adherent to the good manufacturing requirements.
Since early 2009, Caraco has taken part in voluntary drug product recalls, in an effort to protect the public from possible defective medications. Manufacturing defects included: oversized tablets and potential formulation errors.
The FDA admits that the confiscation could effect a shortage of choline magnesium trisalicylate oral tablets, medicine frequently used for pain management. They advise health care practitioners (in an event of a shortage) to consider alternative, safe, appropriate treatments.
