NEW BRUNSWICK, NJ—A Johnson & Johnson subsidiary pleaded guilty on March 10 to a federal criminal charge that it sold infants and children's over-the-counter (OTC) liquid medicine that had been "adulterated" with contaminants due to bad manufacturing processes.
“As part of the criminal resolution, McNeil [Consumer Healthcare], a wholly owned subsidiary of Johnson & Johnson, agreed to pay a criminal fine of $20 million and forfeit $5 million,” reads a US Department of Justice announcement.
“McNeil-PPC Inc. entered a guilty plea in Federal District Court in Philadelphia to one count of an information charging the company with delivering for introduction into interstate commerce adulterated infants’ and children’s over-the-counter (OTC) liquid medicines.”
The medicines included Infants’ and Children’s Tylenol and Infants’ and Children’s Motrin.
"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," reads the release.
"According to the information, the foreign material was later identified as including nickel/chromium-rich inclusions, which were not intended ingredients in this OTC liquid drug."
“Drug quality – and especially with the medicines we give our children – is of paramount concern to the FDA,” said Commissioner Margaret A. Hamburg M.D. of 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. 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.”
According to the criminal charge, the liquid medicines were adulterated because 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), states the release.
"The U.S. District Court for the Eastern District of Pennsylvania accepted McNeil’s guilty plea," reads the release.
McNeil must still abide by a permanent injunction entered by the U.S. District Court in 2011 that requires the company to make remedial measures before reopening its manufacturing facility in Fort Washington, Pennsylvania.
“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.”
“The law requires that drugs be produced under the most rigorous of quality standards,” said First Assistant U.S. Attorney Lappen.
“When companies fail to exercise the vigilance that the law demands, they will held be accountable. Drug companies should be aware that failing to adhere to good manufacturing practices subjects them to penalties and prosecution.”
"In connection with receiving this consumer complaint, McNeil did not initiate or complete a Corrective Action Preventive Action (CAPA) plan, as alleged in the charging document," says the release.
Allegedly, there were numerous 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.
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.
“The document revealed 30 batches of OTC liquid drugs, including Infants’ Tylenol, Children’s Tylenol, and Children’s Motrin, states the release.
The FDA asked McNeil for the CAPA plan covering the particles and foreign material found in the Infants’ and Children’s OTC drugs, but a McNeil employee “confirmed that McNeil did not have such a CAPA plan.”
The release added that: "Acting Assistant Attorney General Mizer and First Assistant U.S. Attorney Lappen commended the investigative efforts of the FDA’s Office of Criminal Investigations."
The company has been implementing enhanced quality and oversight standards across its entire business, Carol Goodrich, a McNeil spokeswoman, said in a statement.
“This plea agreement fully and finally resolves the federal government’s investigation, and closes a chapter on actions that led the company to review and significantly improve its procedures,” said Goodrich.