The company has also agreed to pay a $25 million settlement with the U.S. Department of Justice, Time.com reports.
In 2010, the company recalled a slew of over-the-counter medicines — including Infants’ Tylenol and Children’s Motrin. This huge recall came right after another batch of huge recalls that involved hundreds of millions of bottles of Tylenol, Motrin, Benadryl and a spate of other consumer products, Time reports. The liquid medications were contaminated with metal particles, were moldy smelling, and also suffered labeling problems.
In May 2009, a consumer complained after noticing the “black specks” in the bottom of a bottle of Infants’ Tylenol, and that’s when problems arose, Reuters reports. It was discovered that the specks were particles of nickel and chromium.
In the U.S., Johnson & Johnson’s 2010 consumer product sales plummeted by more than 19 percent, and this was a decrease of $900 million. The deluge of medicine recalls in 2009 and 2010 played a large part in the first ever back-to-back years of declining sales for the company since World War II.
The subsidiary, based in Pennsylvania, admitted Tuesday that it failed to take corrective action immediately after finding that nickel, iron, and chromium particles were inadvertently added to the medication during the manufacturing process, Consumerist reports.
No injuries have occurred as a result of the contaminated medications, the company reports.
While the recalls were going on in 2010, the Food and Drug Administration and the House Committee on Oversight and Government Reform began investigating the company’s manufacturing processes, Consumerist reports.
When the FDA investigated, it found bacteria in raw materials where the medications were manufactured at the company’s plant in Fort Washington, PA. Not quite a month later, Johnson & Johnson announced it was closing the plant for upgrades, and in so doing, laid off nearly 300 employees. Although the company planned to reopen the plant in 2011, it’s still closed, the AP reported, per Consumerist.
The company, in an operating agreement with the FDA, is also required to undergo increased inspections and oversight.
“McNeil’s failure to comply with current good manufacturing practices is seriously troubling,” Benjamin Mizer, acting Assistant Attorney General, said in a statement Tuesday. “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.”
McNeil has significantly improved its manufacturing processes since the recalls began, said a company representative.
“McNeil has been implementing enhanced quality and oversight standards across its entire business to ensure we are able to meet our commitment to consumers, patients, and doctors who rely on our products,” a spokesperson told the AP, per Consumerist.
The plea agreement “closes a chapter,” a spokesman for McNeil said, adding that the company has “been implementing enhanced quality and oversight standards across its entire business,” Reuters reports, per Time.com.
