A Johnson & Johnson subsidiary pleaded guilty on Tuesday to selling liquid medicine contaminated with metal and agreed to pay $25 million to resolve the case, the U.S. Department of Justice said on Tuesday.
The subsidiary, McNeil Consumer Healthcare, pleaded guilty to one federal criminal charge in the case.
In 2010, the company launched mass recalls of certain children’s over-the-counter-medicines, including Infants’ Tylenol and Children’s Motrin, made at its Fort Washington, Pennsylvania plant.
It was the latest in a series of recalls at the time. There were far-reaching multiple recalls from 2008 to 2010 involving hundreds of millions of bottles and packages of consumer brands such as Tylenol, Motrin, Rolaids, Benadryl and other products due to faulty manufacturing. The recalls kept widely used products such as Children’s Tylenol off pharmacy shelves and seriously tarnished J&J’s once-sterling reputation.
In addition to metal particles getting into liquid medicines, there were moldy odors and labeling problems. For example, the label for Sudafed allergy tablets incorrectly repeated the word “not” to say “do not not divide, crush, chew or dissolve the tablet.
The Johnson & Johnson subsidiary 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.A Food and Drug Administration investigation traced the problem to machinery at the Fort Washington plant, which included manufacturing violations and airborne contamination from a chemical used for wood pallets, Drugwatch reported. The suburban Philadelphia location was shuttered in April 2010, rebuilt from the ground up, but has yet to re-open. The closing of the factory caused supply disruptions for several of McNeil’s over-the-counter pharmaceuticals, the company said in a March 2013 statement.