J&J pleads guilty over children’s contaminated medicine
pharmafile | March 12, 2015 | News story | Manufacturing and Production, Sales and Marketing | FDA, J&J, JJ, McNeil, OTC, Tylenol, consta, hamburg, recall
Johnson & Johnson’s consumer division McNeil has pleaded guilty and will pay fines of $25 million for wrongdoings regarding its children’s pain medicines.
The over-the-counter (OTC) drugs manufacturer has been charged with delivering drugs into the market contaminated with harmful metals.
Black specks were discovered in bottles of its children’s medicine Tylenol (acetaminophen) and Motrin (ibuprofen), both aimed at relieving minor aches and pains in youngsters.
“Drug quality – especially with the medicines we give our children – is of paramount concern to the FDA. The FDA expects manufacturers to have systems in place that will quickly discover and correct problems with medical products before they enter the US marketplace,” says Margaret Hamburg, who is the (shortly to resign) commissioner of the US Food and Drug Administration.
“Today’s guilty plea holds accountable those corporations who risk jeopardising the public health by not adhering to the high standards set for drug manufacturers.”
The foreign material was later identified by the FDA’s office of criminal investigations as nickel and chromium-rich inclusions, both were not intended ingredients in the OTC drugs.
According to the US Department of Justice (DOJ) McNeil did not initiate or complete an investigation after receiving the initial complaint. A subsequent 2010 inspection of the company’s Fort Washington facility revealed 30 batches of the liquid drugs contained the metals.
J&J has continued to struggle with quality problems at its OTC division for some time now, as similarly in 2013 – 200,000 bottles of Motrin were recalled due to contamination with plastic particles. The year before a recall of Risperdal Consta (risperidone) vials was initiated after the discovery of mould during routine quality testing.
Furthermore, in 2011 two of McNeil’s manufacturing facilities in Fort Washington and Las Piedras, Puerto Rico were placed under a consent decree by the FDA for persistent failures to meet quality standards. The firm also commenced a series of product recalls between 2009 and 2010.
Benjamin Mizer, who is the acting assistant attorney general at the DOJ concluded: “McNeil’s failure to comply with current good manufacturing practices is seriously troubling.”
Tom Robinson
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