A subsidiary of Johnson & Johnson has pleaded guilty to selling liquid medications that had been contaminated with metal during the manufacturing process, the U.S. Department of Justice says.
McNeil Consumer Healthcare, the subsidiary, has agreed to pay a $25 million settlement after pleading guilty in a Federal District Court in Philadelphia to a single federal criminal charge, the manufacture and processing of adulterated over-the-counter medicines, the department announced.
Prosecutors said the company was aware of the problem for almost a year but failed to take timely steps to fix it.
"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," Acting Assistant Attorney General Benjamin C. Mizer said after a judge accepted McNeil's settlement plea.
In 2010, McNeil Consumer Healthcare issued a recall for over-the-counter medications, including Children's Motrin and Infants' Tylenol manufactured at its plant in Fort Washington, Pennsylvania.
In May 2009, a consumer complained about noticing "black specks" at the bottom of a bottle of Infants' Tylenol. The specks were later determined to be nickel and chromium particles.
The recall of Infant's Tylenol and Children's Motrin, which kept the widely-used medications off pharmacy shelves, followed a flurry of recalls between 2008 and 2010 that involved hundreds of millions of packages of Tylenol, Motrin, Benadryl and other consumer health products, all recalled for faulty manufacturing.
In addition to the metal particles making their way into liquid medicines, there were problems with mold odors and confusing labeling instructions.
In one instance, people who bought Sudafed allergy tablets found themselves reading label instruction that, because of incorrectly repeating the word "not," read as a confusing "do not not divide, crush, chew or dissolve the tablet."
The rash of recalls seriously tarnished Johnson & Johnson's reputation, and in 2010 the company lost an estimated $900 million in sales.
A McNeil Consumer Healthcare spokeswoman, Carol Goodrich, said the plea agreement and $25 million settlement "closes a chapter."
In addition, she said, the company has "been implementing enhanced quality and oversight standards across its entire business" and under the terms of the agreement with the Justice Department would put additional safety measures in place before reopening its manufacturing facility in Fort Washington.
Johnson & Johnson, headquartered in New Brunswick, New Jersey, has around 250 subsidiary companies operating in more than 57 countries, and its pharmaceutical and consumer health products are sold in over 175 countries.