Via this report on the Fierce Pharma Website
Johnson & Johnson's ($JNJ) McNeil Consumer Healthcare may have cleaned up its act over the past 6 years, but the company is again being bit in the behind by the problems that sprung from the mess that its OTC plant in Pennsylvania once was. The company has pleaded guilty to a federal misdemeanor charge and will pay a $20 million fine and forfeit another $5 million for allowing Infants' Tylenol, Children's Tylenol and Children's Motrin products into the market that were tainted with metals.
The plea agreement announced by Justice Department and FDA officials today stemmed from a complaint that McNeil's plant in Fort Washington, PA, received May 1, 2009, that there were black specks in some of its children's pain medicines. But instead of starting an investigation to find out why, Johnson & Johnson ($JNJ) let it slide, according to the DOJ release.
The particles were later determined to be "nickel/chromium-rich inclusions" and not ingredients that should have been in the products taken by children throughout the world, court records indicate. The FDA would later get from McNeil a list of 30 OTC drug batches with "non-conformances for particles" that occurred in roughly a year's time. In April 2010, McNeil recalled all lots of certain unexpired OTC drugs made for infants and children that it had shipped worldwide.
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