In an effort to curb product liability issues, the federal government is taking over three Tylenol plants. The take-overs come after a flurry of drug recalls and a criminal investigation into safety concerns at the three plants by the Food and Drug Administration. Yesterday, the FDA along with the Justice Department took legal action against McNeil PPC, the company that owns the factories, and two company executives in charge of quality and operations.
McNeil, a company owned by Johnson & Johnson, failed to meet federal manufacturing practices in three of its factories. The factories are located in Lancaster, Pennsylvania, Fort Washington, Pennsylvania and Las Piedras, Puerto Rico. The legal action outlines a timeline for the company to bring its manufacturing practices up to the federal standard. Also, McNeil must use an independent safety expert to inspect the plants for violation corrections. After inspection the FDA will determine if the measures fit federal law.
If the company does not abide by the corrective measures, the FDA will order McNeil to stop manufacturing, recall products and fine the company $15,000 for each day of noncompliance and $15,000 for each violation. The company’s agreement to take corrective actions has forestalled a civil lawsuit that could be brought by the FDA; however, the agreement has not stopped the Justice Department’s criminal investigation.
McNeil has issued multiple recalls during 2010 for over-the-counter cold medicines such as Motrin, Benadryl and Tylenol produced at the three locations. The agreement requires the company to destroy all drugs in its possession that have been manufactured at the three locations since 2009. The plants in Lancaster and Puerto Rico will continue to operate during the corrective time period.
