Johnson & Johnson’s McNeil-PPC Inc. subsidiary has agreed to plead guilty to charges that it knowingly allowed tens of millions of bottles of children’s drugs to be shipped out, even though they were contaminated with metal particles.

According to a Justice Department and FDA press release issued on March 10, the drug maker will pay $25 million in fines and forfeitures as part of a settlement that results charges that McNeil violated the federal Food, Drug and Cosmetic Act (FDCA) when it shipped out millions of bottles of Infants’ Tylenol, Children’s Tylenol, Children’s Motrin and other over-the-counter drugs despite knowing that they were contaminated with dark flecks which turned out to be metal particles.

“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,” FDA Commissioner Dr. Margaret Hamburg said in the press release. “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 initial McNeil Healthcare children’s medication recall on April 30, 2010, affected 40 different liquid medication products, including Tylenol, Benadryl, Motrin and Zyrtec. McNeil is a subsidiary of Johnson & Johnson.

The recall affected 136 million bottles of children’s medications, and resulted in the shutdown of the company’s Ft. Washington, Pennsylvania, plant, and the suspension of the production of all of McNeil’s children medications.

Following that recall, the FDA received nearly 800 complaints of problems associated with the drugs, including at least seven reports of deaths among children using the medications.

Court documents have revealed that McNeil began receiving complaints as early as May 1, 2009, about a year before it announced the recall. The first consumer complaint warned that there were black specks in the liquid of Infant’s Tylenol, but the company failed to address the complaint in conformance with current Good Manufacturing Practices. The material was later identified as nickel/chromium-rich inclusions.

There were several instances where the company found metal particles in bottles of Infant Tylenol at the Fort Washington plant, but the company repeatedly failed to address them properly. The company did not recall the drugs until after FDA inspections revealed the problems and that the company did not have a Corrective Action Preventative Action (CAPA) plan to deal with the problem.

The company was hit by a consent decree filed by the U.S. Department of Justice Office of Consumer Litigation, and the U.S. Attorney’s Office for the Eastern District of Pennsylvania.

The decree shut down the Fort Washington plant and required the company to destroy the affected drugs, and to hire independent experts on current Good Manufacturing Procedures to oversee rehabilitation of the Fort Washington facility, as well as plants in Lancaster, Pennsylvania and Las Piedras, Puerto Rico. The company had to pay all of the FDA’s employee, laboratory, and mileage expenses as part of the deal.

The company faced fines of up to $10 million a year if it failed to comply with the consent decree and remains under a permanent injunction to make necessary changes before it can reopen the Fort Washington facility.

This week’s agreement adds a $20 million criminal fine and $5 million in profit forfeitures to the penalties already faced by the company.

“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 be held accountable,” First Assistant U.S. Attorney Louis D. Lappen said in the press release. “Drug companies should be aware that failing to adhere to good manufacturing practices subjects them to penalties and prosecution.”

Tags: Benadryl, Childrens Drugs, Childrens Tylenol, Johson & Johnson, Motrin, OTC, Particulate Matter, Pennsylvania