A subsidiary of Johnson & Johnson pleaded guilty in federal court Tuesday and agreed to pay a $25 million settlement for selling medicine contaminated with metal flakes.
Reuters reports McNeil Consumer Healthcare, the subsidiary of the healthcare and pharmaceutical behemoth Johnson & Johnson, pleaded guilty in Federal District Court in Philadelphia to a single criminal charge of the manufacture and process of adulterated over-the-counter medicines and agreed to pay the settlement to the U.S. Department of Justice.
The settlement follows a mass recall, issued by the company in 2010, for children’s medicines including Infants’ and Children’s Tylenol and Children’s Motrin, that were manufactured at the company’s plant in Fort Washington, Pennsylvania.
Federal prosecutors alleged the company knew about the contamination and failed to take the proper steps to fix the manufacturing process.
According to Reuters, the first reported incident happened in 2009 when a consumer complained of noticing “black specks” in the bottom of a Infant’s Tylenol bottle. Subsequent tests found the specks were nickel and chromium, believed to have been introduced into the medicine during manufacturing and bottling.
Although prosecutors agreed with the company’s assertion that no one was injured because of the contamination, Acting Assistant Attorney General Benjamin Mizer told the judge in a statement that the company’s failure to comply with good manufacturing practices was “seriously troubling.”
"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,” Mizer said, according to The Associated Press.
The AP reported that McNeil continued to manufacture the medicine for several months after learning about the specks in 2009.
Michael Schwartz, an attorney for McNeil, spoke to the AP about the settlement and the allegations Tuesday.
“There were investigative steps taken, but not all of the steps required under all of our internal operating procedures,” Schwartz admitted.
The debacle was one among many for Johnson & Johnson between 2008 and 2010. The company issued multiple recalls during those years for packaging and labeling problems with numerous popular products including Benadryl and Rolaids, according to Reuters.
Those recalls were thought be largely responsible for the 19 percent drop in sales the company experienced in 2009.
McNeil spokeswoman, Carol Goodrich, said Tuesday that the settlement “closes a chapter” for the company that has since cleaned up its act.
“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,” she said.