Article: KV Pharmaceutical Faces New Restrictions From the FDA


March 2, 2009, the US Food and Drug Administration (FDA) announced it had filed a Consent Decree of permanent injunction against KV Pharmaceutical Company, which is known primarily for making generic heart drugs. The injunction enjoins KV Pharmaceutical, its subsidiaries Ther-Rx Corporation and ETHEX Corporation, and its principal officers from making or distributing unapproved and adulterated drugs.

Only months before the injunction, ETHEX, a wholly owned subsidiary of KV Pharmaceutical, announced the recall of nine lots of generic drugs over safety concerns. The recalled lots, which had shipped prior to May 22, 2008, were of drugs for the treatment of low blood pressure and irregular heartbeat that the FDA said may be in the form of oversized tablets with potentially life-threatening doses of active ingredients. The drugs recalled were dextroamphetamine sulfate, isosorbide mononitrate, morphine sulfate, and propafenone HCl.

Inspections of KV Pharmaceutical facilities conducted in late 2008 and early 2009 found significant federal violations with regard to the production and shipping of prescription drugs. The injunction prevents KV Pharmaceutical from making or selling drugs until the FDA determines that the companys products and procedures are brought into compliance with the law, and remains in place until new drug approval requirements and compliance with current Good Manufacturing Practice (cGMP) is sustained continuously for six years.

Violations of the injunction subject KV Pharmaceutical to damages of $15,000 per day for each violation, up to $5 million per year. The FDA stated that it would carefully monitor the company to ensure that it complies with the injunction.

"Consumers need to be confident that drugs meet our manufacturing requirements for identity, strength, purity, and quality, and have been evaluated by the FDA for safety and efficacy, said Janet Woodcock, M.D., director of FDAs Center for Drug Evaluation and Research (CDER). Based on the agencys inspections of the KV Pharmaceuticals facilities, the FDA was evidently not able to provide such an assurance for this companys products.

If you or a loved one has been injured as a result of taking medications manufactured, marketed, or distributed by KV Pharmaceutical or its subsidiaries, you may be entitled to compensation. Contact a qualified pharmaceutical injury attorney for an evaluation of your case.