PHILADELPHIA – McNeil-PPC Inc. pleaded guilty today to violating the federal Food, Drug and Cosmetic Act (FDCA) with regard to infants' and children's liquid medications, including Infants' Tylenol, Children's Tylenol and Children's Motrin. McNeil, a wholly owned subsidiary of Johnson & Johnson, was charged with delivery for introduction into interstate commerce drugs that were deemed adulterated. It is a misdemeanor. The company will pay a criminal fine of $20 million and forfeit $5 million.
The guilty plea and resolution were announced today by First Assistant U.S. Attorney Louis D. Lappen, Acting Assistant Attorney General Benjamin C. Mizer of the Justice Department's Civil Division, and Director George M. Karavetsos, with FDA's Office of Criminal Investigations.
According to court documents, the OTC liquid drugs manufactured by McNeil at its Fort Washington facility were bottled on four lines of machinery dedicated to liquid formulations. On or about May 1, 2009, 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, which were not intended ingredients in this OTC liquid drug. In connection with receiving this consumer complaint, McNeil did not initiate or complete a Corrective Action Preventive Action (CAPA) plan in conformance with current Good Manufacturing Practices.
The information alleges other instances in which McNeil found metal particles in bottles of Infants' Tylenol at its Fort Washington facility, but failed to initiate or complete a CAPA. According to the information, during a 2010 Inspection of McNeil's Fort Washington facility, the U.S. Food and Drug Administration (FDA) asked McNeil for a list with all non-conformances for particles and the associated OTC drug batches that had occurred since an FDA inspection in 2009. As noted in the information, this document revealed 30 batches of OTC liquid drugs, including Infants' Tylenol, Children's Tylenol, and Children's Motrin. 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 McNeil did not have such a CAPA plan.
On or about April 30, 2010, McNeil Consumer Health Care, a division of McNeil, in consultation with the FDA, announced that the company was recalling all lots of certain unexpired Infants' and Children's OTC drugs manufactured at McNeil's Fort Washington facility and distributed in the United States and other countries around the world. McNeil's recall included, but was not limited to, Infants' and Children's Tylenol and Infants' and Children's Motrin.
Under the law, a drug is adulterated if the methods used in, or the facilities and controls used for, the manufacture, processing, packing, labeling, holding and distribution of drugs and components were not in conformance with cGMP requirements for drugs. Drugs not manufactured, processed, packed, labeled, held and distributed in conformance with cGMP requirements are adulterated as a matter of federal law, without any showing of actual defect.
McNeil remains under a 2011 permanent injunction entered by the U.S. District Court in the Eastern District of Pennsylvania, requiring it to, among other things, make remedial measures before reopening its manufacturing facility in Fort Washington, Pennsylvania.
"The law requires that drugs be produced under the most rigorous of quality standards. When companies fail to exercise the vigilance that the law demands, they will held be accountable" said Lappen. "Drug companies should be aware that failing to adhere to good manufacturing practices subjects them to penalties and prosecution.
"McNeil's failure to comply with current good manufacturing practices 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."
"Drug quality – and especially with the medicines we give our children – is of paramount concern to the FDA. The FDA expects manufacturers to have systems in place that will quickly discover and correct problems with medical products before they enter the U.S. marketplace," said Margaret A. Hamburg, M.D., Commissioner, U.S. Food and Drug Administration. "Today's guilty plea holds accountable those corporations who risk jeopardizing the public health by not adhering to the high standards set for drug manufacturers."
The case was investigated by the Food and Drug Administration Office of Criminal Investigations. It is being prosecuted jointly by Assistant U.S. Attorney Mary Beth Leahy and Jeffrey Steger, Assistant Director with the Department of Justice Civil Division's Consumer Protection Branch. Assistance is being provided by Consumer Protection Branch Trial Attorney Kathryn Drenning and Associate Chief Counsel for Enforcement Laura Pawloski, with the Department of Health and Human Services' Office of General Counsel's Food and Drug Division.