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Maker of Children’s Tylenol to plead guilty over recall

2 min read

A subsidiary of Johnson & Johnson agreed to plead guilty Tuesday to a federal criminal charge that it sold over-the-counter infant’s and children’s liquid medicine that contained metal particles.

McNeil Consumer Healthcare, of Fort Washington, Pennsylvania, is expected to acknowledge selling adulterated bottles of Infants’ and Children’s Tylenol and Children’s Motrin at a plea hearing Tuesday afternoon. The company agreed to pay $25 million to resolve the case, according to court documents.

Metal particles, including nickel, iron and chromium, were introduced during the manufacturing process at McNeil’s plant in Fort Washington. Prosecutors said McNeil knew about the problem for nearly a year but failed to take immediate steps to fix it.

“The proposed criminal resolution is sufficient to punish McNeil for its past failures and to deter McNeil from violating” federal law in the future, prosecutors wrote in a memo to the judge overseeing the case.

McNeil is a unit of Johnson & Johnson. The New Brunswick, New Jersey, health care giant has struggled with scores of product recalls since 2009.

In this case, McNeil first learned of the particle problem in May 2009, when a consumer complained about black specks inside a bottle of Infants’ Tylenol, according to court documents. McNeil subsequently found metal particles during production but continued making the liquid medicines for several more months.

McNeill eventually traced the problem to the machinery at its plant in Fort Washington and issued a recall. The Food and Drug Administration said the potential for serious medical problems was remote but advised consumers to stop using the medicine.

The suburban Philadelphia plant — which was linked to several recalls of Tylenol and other nonprescription drugs for children and adults — 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.

Johnson & Johnson had no immediate comment on the guilty plea.

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Associated Press business writer Linda A. Johnson contributed to this story from Trenton, New Jersey.

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