The manufacturer failed to act on the discovery of metal contaminants in products
McNeil-PPC Inc has pleaded guilty in the Federal District Court in Philadelphia, US to producing adulterated infant's and children’s over-the-counter (OTC) liquid medicines. McNeil, a wholly owned subsidiary of Johnson & Johnson, agreed to pay a fine of US$20m and forfeit $5m.
According to the charge, the medicines 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).
The US District Court accepted McNeil’s guilty plea, but McNeil remains subject to a permanent injunction entered by the US District Court in 2011, requiring the company, among other things, to make remedial measures before reopening its manufacturing facility in Fort Washington, Pennsylvania.
'McNeil’s failure to comply with cGMP is seriously troubling,' said Acting Assistant Attorney General Mizer. '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 Infants’ and Children’s Tylenol and Motrin were bottled on four equipment lines dedicated to liquid formulations. McNeil received a complaint from a consumer regarding the presence of 'black specks in the liquid on the bottom of the bottle' of Infants’ Tylenol. The foreign material was later identified as including nickel/chromium-rich inclusions. McNeil failed to initiate or complete a Corrective Action Preventive Action (CAPA) plan after receiving this complaint.
During a 2010 inspection of the Fort Washington facility, the US Food and Drug Administration (FDA) asked for a list with all non-conformances for particles and the associated OTC drug batches that had occurred since an FDA inspection in 2009. This revealed 30 batches of OTC liquid drugs. During the 2010 inspection, the FDA asked McNeil for the CAPA plan covering the particles and foreign material found in the infants’ and children’s OTC drugs, and a McNeil employee confirmed that the company did not have such a plan.
Several batches of the products were recalled by McNeil in 2010.