Nearly five years after McNeil Consumer Healthcare – a subsidiary of Johnson & Johnson – began recalling over-the-counter Infant’s and Children’s Tylenol and Children’s Motrin, the company has acknowledged that it knowingly sold the cold medication that contained metal particles and agreed to pay $25 million to resolve the case.
The Associated Press reports that McNeil Consumer Healthcare pleaded guilty to a federal charge that it sold contaminated medication for nearly a year after uncovering the issue.
The Pennsylvania-based subsidiary admitted on Tuesday that it failed to take immediate corrective action after discovering that the manufacturing process at the company’s Fort Washington, PA, plant introduced nickel, iron and chromium particles into the medication.
To date, the company says no injuries have occurred as a result of the contaminated meds.
The AP reports that the issue first came to light for the company in May 2009, when a consumer complained about black specks inside a bottle of Infants’ Tylenol. Despite verifying that the medication contained metal particles, McNeil continued to produce and sell the products for nearly a year.
In May of 2010, the company finally launched a massive recall of millions of bottles of the infant and children’s liquid medication, as well as other products.
Around that same time, the Food & Drug Administration and the House Committee on Oversight and Government Reform opened investigations into the company’s production processes.
An FDA investigation found that the plant producing the medication contained bacteria in raw materials, poor quality controls and general dirtiness.
Less than a month later, Johnson & Johnson announced it would close the plant for upgrades, laying off nearly 300 workers. While the company planned to reopen the plant in 2011, the AP reports it remains closed.
The company is currently operating under an agreement with the FDA that requires it to undergo increased inspections and oversight, the AP reports.
“McNeil’s failure to comply with current good manufacturing practices is seriously troubling,” Acting Assistant Attorney General Benjamin Mizer said in a statement on 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.”
A representative for McNeil said it has significantly improved its manufacturing processes since the recalls began.
“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,” a spokesperson tells the AP.
Maker of Children’s Tylenol pleads guilty to selling products that contained metal particles [The Associated Press]