$25M Fine Paid by Johnson & Johnson in Children’s Tylenol Case

Consumer products company Johnson & Johnson has pleaded guilty and will pay a $25 million fine for failing to maintain safe manufacturing processes in the production of Infants’ and Children’s Tylenol and Children’s Motrin liquids from 2009 to 2010 at a manufacturing plant in Fort Washington in Montgomery County, Pa.

The fine and the guilty plea were announced on March 10 in federal court in Philadelphia, where the company was rebuked for failing to quickly take corrective action after small metal particles were found to have contaminated bottles of the medicines, according to a story in The Philadelphia Inquirer.

The plea came after metal particles, including nickel and chromium, were found in children’s liquid medicine made at the McNeil Consumer Healthcare plant in Fort Washington from May 2009 through April 2010, the story reported. The fine was calculated as a percentage of the sales of those products during that time period, according to the paper. McNeil is a division of Johnson & Johnson.

“Prosecutors said McNeil knew about the problem for nearly a year but failed to take immediate steps to fix it,” according to a March 10 report by The Associated Press.

In a statement, acting Assistant Attorney General Benjamin C. Mizer called McNeil’s failure to comply with current good manufacturing practices “seriously troubling,” the Inquirer reported.

The case unfurled in early May 2009 when a customer reported to McNeil that they had found “black specks” in the liquid on the bottom of a bottle of Infants’ Tylenol, according to documents filed in the case, the story reported. The customer returned the bottle to McNeil to provide evidence of the problem.

Some 30 batches of the medicines were found to have metal in them by April 2010, the story reported. The particles were later was found to be from a machine part that was “a composite metal that is mostly nickel, but also includes tin, iron, bismuth and chromium.”

No children were reported to have been injured by the metal particles, according to the company.

McNeil halted the production of the affected medicines five days after finding tainted medicine on its production lines in April 2010, and finally issued a recall notice at the end of that month, the story reported.

McNeil’s Fort Washington plant has not been producing medicine since the production lines were halted back in 2010. The plant cannot reopen until the company proves to the government that improvements have been made and that no more faulty medicines can be produced, the story reported.

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