Children’s Tylenol Manufacturer Pleads Guilty to Selling Tylenol Contaminated With Metal Particles

By Rheingold Giuffra Ruffo & Plotkin LLP

Infants’ and Children’s Motrin and Tylenol were found contaminated with nickel, iron, and chromium particles. McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, pleaded guilty in March of 2015 to a federal criminal charge that it sold over the counter medicines containing metal particles.

McNeil Consumer Healthcare failed to take corrective action after discovering the adulterated bottles of medicine. In its guilty plea McNeil agreed to pay $25 million. The children’s medicines were contaminated during the manufacturing process at McNeil’s manufacturing plant in Pennsylvania. According to Federal Prosecutors McNeil knew about the problem for almost a year yet failed to take steps to remedy it.

The company claimed no one was injured by the metal particles. Even if no children were injured McNeil’s failure to comply with manufacturing practices is very disconcerting. Johnson & Johnson, McNeil’s parent company, has faced many product recalls in the past few years. Toward the end of 2009, the company recalled Tylenol, Motrin, and Benadryl after consumer complaints of stomach pains and diarrhea.

In regards to the case at hand, McNeil learned of the metal contaminants in May of 2009, when a consumer reported black specks inside a bottle of Infants’ Tylenol. McNeil then found metal particles during the production process but continued making the medicine for several more months. Although McNeil did conduct an investigation the necessary steps to cure the contamination were not taken for some time. A few months after it was first on notice McNeil traced the contamination to a manufacturing plant in Pennsylvania. Although the FDA said the potential for serious medical problems was improbable it advised consumers to stop using the medicine.

Since the incident in 2009, the Pennsylvania manufacturing plant was rebuilt and McNeil claims it is operating under enhanced quality and oversight standards across its entire business.

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