Maker Of Children's Tylenol Contaminated With Metal Particles Pleads
Guilty
A subsidiary of Johnson & Johnson pleaded guilty Tuesday to a federal criminal charge that it
sold over-the-counter infant’s and children’s liquid medicine containing metal particles.

McNeil Consumer Healthcare, of Fort Washington, Pennsylvania, acknowledged failing to take
corrective action after discovering the adulterated bottles of Infants’ and Children’s Tylenol and
Children’s Motrin. The company agreed to pay $25 million to resolve the case.

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 company and prosecutors said in court Tuesday that no one was injured.

"McNeil’s failure to comply with current good manufacturing practices is seriously troubling,"
Acting Assistant Attorney General Mizer said in a statement after the judge accepted McNeil’s
plea.

"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," he said.

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 late 2009, the company recalled Tylenol,
Motrin, and Benadryl after consumers reported a moldy odor coming from newly opened bottles
and complaints of stomach pains and diarrhea were filed.

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.

"There were investigative steps taken, but not all of the steps required under all of our internal
operating procedures," company attorney Michael Schwartz told The Associated Press on
Tuesday.

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.

McNeil said Tuesday it has significantly improved its procedures.

"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," company spokeswoman Carol Goodrich said.
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