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news.Johnson & Johnson's McNeil-PPC has pleaded guilty to a federal criminal charge that it sold over-the-counter (OTC) infant's and children's liquid medicine containing metal particles.
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As per the information, the OTC liquid drugs manufactured at the company’s Fort Washington facility, including Infants’ and Children’s Tylenol and Infants’ and Children’s Motrin, were adulterated. They were not manufactured, processed, packed or held in conformance with current Good Manufacturing Practices (cGMP), in violation of the federal Food, Drug and Cosmetic Act (FDCA).
These OTC liquid drugs manufactured at the Fort Washington facility were bottled on four lines of machinery dedicated to liquid formulations.
Justice Department Civil Division acting assistant attorney general Benjamin Mizer said: "McNeil’s failure to comply with current good manufacturing practices is seriously troubling.
"The Department of Justice will continue to be aggressive in pursuing and punishing companies such as McNeil that disregard a process designed to assure quality medicines, especially OTC drugs for infants and children."
The company first learned of the particle problem in May 2009, when a consumer complained about black specks inside a bottle of Infants’ Tylenol.
The foreign material including nickel/chromium-rich inclusions, which were not intended ingredients in this OTC liquid drug, but upon receiving the consumer complaint, the company did not start or complete a Corrective Action Preventive Action (CAPA) plan.
During a 2010 inspection at the Fort Washington facility, the US Food and Drug Administration (FDA) asked the company for a list with all non-conformances for particles and the associated OTC drug batches that had occurred since an FDA inspection in 2009.
The Fort Washington plant, which was linked to several recalls of Tylenol and other OTC drugs for children and adults, was shut down in April 2010 and completely rebuilt, but is yet to re-open.
In order to resolve this issue, the company has agreed to pay a criminal fine of $20m and forfeit $5m.
The US District Court for the Eastern District of Pennsylvania accepted the company’s guilty plea.