It's the kind of news parents would want a company to admit to—but really don't want to hear: A Johnson & Johnson subsidiary will pay $25 million after pleading guilty yesterday to a federal criminal charge that it sold over-the-counter Infants' and Children's Tylenol and Children's Motrin containing metal particles. McNeil Consumer Healthcare acknowledged failing to take corrective action after discovering that metal particles, including nickel, iron, and chromium, were introduced during the manufacturing process at its Fort Washington, Penn., plant. Prosecutors said McNeil first learned of the particle problem in May 2009, when a consumer complained about black specks on the bottom of a bottle of Infants' Tylenol. But McNeil continued making the liquid medicines, even though by April 2010 it had identified 30 batches containing metal particles, reports the Philadelphia Inquirer.
It eventually traced the problem to a machine part at its plant in Fort Washington and stopped production on one line on April 13; roughly two weeks later it issued a recall. No children were injured. "There were investigative steps taken, but not all of the steps required under all of our internal operating procedures," a company attorney told the AP yesterday. It's far from the first issue for McNeil: The FDA alleged in 2010 that McNeil discovered some of its products contained a chemical normally found in wooden shipping pallets in 2008, but didn't recall the medicine until 2009. The suburban Philadelphia plant was shuttered in April 2010 and rebuilt from the ground up, but it has yet to reopen. The company is operating under an agreement with the FDA requiring increased inspections and oversight at its factories.