Tylenol Makers Fined $25 Million For Selling Contaminated Children’s Medicine

Tylenol has been ordered to pay a $25 million criminal fine for selling children’s medication which was contaminated with “particles.” McNeil-PPC Incorporated, a Johnson & Johnson subsidiary, pleaded guilty to one misdemeanor count relating to the medication it manufactured that prompted a 2009 recall.

The Tylenol recall included both contaminated children’s and infant’s over-the-counter medication. Tens of thousands of bottles Tylenol and Motrin made at the McNeil facility in Fort Washington, Pennsylvania, were included in the 2009 recall. The particles found floating in the contaminated Tylenol, which prompted complaints from parents, were found to be small pieces of metal. McNeil-PPC reportedly maintained that the small pieces of metal in the Tylenol did not pose any safety risks or health risks to children and infants.

During an investigation into the Tylenol facility at Johnson & Johnson McNeil, the FDA found that the process used to make the medicine violated the federal Food, Drug and Cosmetic Act. McNeil did not begin a “Corrective Action Preventive Action Plan” when it first learned about the Tylenol contaminated children’s medicine, according to court documents. The Food, Drug and Cosmetic Act reportedly requires that medications must be manufactured “under the most rigorous of quality standards.”

“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,” Acting Assistant Attorney General Mize said about the Tylenol contaminated children’s medicine case.

McNeil Consumer Healthcare representative Carol Goodrich had this to say about the guilty plea and the $25 million fine for the contaminated Tylenol.

“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. McNeil has been implementing enhanced quality and oversight standards across its entire business to ensure we are best able to meet our commitment to consumers, patients and doctors who rely on our products.”

A Congressional probe into the Tylenol recall revealed that the case of the contaminated infant and children’s medicine was the third such action for involving Tylenol products in less than a year.

“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,” First Assistant U.S. Attorney Lappen noted.

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