FORT WASHINGTON, Pa., March 11 (UPI) -- A Johnson & Johnson subsidiary has agreed to pay a $25 million criminal fine associated with a recall in 2009 of over-the-counter liquid children's medicines that had particles in them.
McNeil-PPC Inc., a wholly owned subsidiary of Johnson & Johnson, pleaded guilty to one misdemeanor count of delivering into interstate commerce adulterated infants' and children's over-the-counter liquid medicines.
Those medicines were part of a recall that included tens of thousands of bottles of infants' and children's Tylenol and infants' and children's Motrin manufactured at the company's Fort Washington, Pa., facility. Customers complained of particles floating in the liquid. Those particles turned out to be small pieces of metal McNeil said didn't pose health or safety risks to consumers.
An FDA investigation into the facility after the recall revealed the medicine wasn't manufactured according to best practices and was in violation of the federal Food, Drug and Cosmetic Act.
"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."
According to the court documents, McNeil failed to initiate a Corrective Action Preventive Action plan after first receiving complaints about the particles in May 2009.
"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."
As part of its plea, McNeil agreed to pay a $20 million fine and forfeit $5 million.
"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 Carol Goodrich, a spokesperson for McNeil Consumer Healthcare. "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."