Johnson & Johnson Guilty Plea for Children’s Tylenol Recall

“The maker of Children’s Tylenol agreed to plead guilty to a federal criminal charge of knowingly selling adulterated bottles of its painkillers for children and infants. The drugs were recalled in 2010 because they contained metal particles.”-Law360

The McNeil Consumer Healthcare Division of McNeil-PPC Inc, paid 20 million in criminal fines and plead guilty to the selling versions of children’s Tylenol and Motrin over the counter with contaminants and metal particles.
On Tuesday they agreed to pay the penalty and plead guilty to the charges made by the U.S, Department of Justice. The medications we manufactured in Fort Washington, Pennsylvania, it was found that there were nickel or chromium contaminants/ According to Prosecutors McNeil will need to pay 20 million and forfeit 5 million as part of the agreement.

Back in 2009 there was consumer complaints about black residue found at the bottom of the Tylenol bottles. Even after this complain McNeil did not take the steps to correct or investigate the allegations made by the consumers.
McNeil pled guilty to one count of misdemeanor violation of the Federal Food Drug and Cosmetic Act.
Acting Assistant Attorney General Benjamin Mizer said “McNeil’s failure to comply with current good manufacturing practices is seriously troubling,”

He also said he would be pursuing and seeking punishment to all those companies failing secure over the counter medications, especially those designated to children.

“The particles may be solidified product ingredients or manufacturing residue such as tiny metal specks,”said Marc Boston, a McNeil spokesman, according to the New York Times.

McNeil knew about the particles in the medication because of the consumer complaints since May 2009, and continued production, and selling of the products for over a year. The voluntary recalls didn’t start until April 2011.

They claimed there hadn’t been any reported injuries.

In Nov 2009 a 4 year old boy, named Joshua dies after taking a dose of the tainted Tylenol, the father files a lawsuit in 2012 but is dismissed in Dec 2014, because the boy dies in 2009 and the recall was reported in 2011.

“A Food and Drug Administration investigation traced the problem to machinery at the Fort Washington plant, which included manufacturing violations and airborne contamination from a chemical used for wood pallets, Drug watch reported. The suburban Philadelphia location was shuttered in April 2010, rebuilt from the ground up, but has yet to re-open. The closing of the factory caused supply disruptions for several of McNeil’s over-the-counter pharmaceuticals, the company said in a March 2013 statement.”-