Johnson & Johnson, maker of Children’s Tylenol and Motrin, has pleaded guilty to charges it sold contaminated products to consumers.
As reported by the Philadelphia Inquirer, the company has agreed to pay a massive fine – $25 million – after pleading guilty to a single criminal count in federal court over poor manufacturing practices at its Fort Washington facility.
The paper said the company’s plea relates to the discovery of metal particles including nickel and chromium that were discovered in children’s liquid medicine manufactured at the McNeil Consumer Healthcare Plant between May 2009 and April 2010. Court documents said the fine was set as a percentage of sales of the tainted products during the 11 months included in the filing and plea.
Quoting Justice Department officials, MarketWatch reported that the company is currently working to bring its Fort Washington plant into compliance and will seek to reopen it once it gets clearance from the U.S. Food and Drug Administration. The plant’s other factories are still operating but are doing so under a 2011 permanent injunction.
“McNeil’s failure to comply with current good manufacturing practices is seriously troubling,” acting Assistant Attorney General Benjamin C. Mizer said in a statement, the paper reported.
Odd smells and poor labeling as well
The Inquirer further reported:
In early May 2009, a customer complained to McNeil about the presence of “black specks in the liquid on the bottom of the bottle” of Infants’ Tylenol, according to the plea agreement and documents filed in Philadelphia by prosecutors, including Assistant U.S. Attorney Mary Beth Leahy and Jeffrey Steger, of the Justice Department’s consumer protection branch. The customer returned the bottle to McNeil, and the company found a mix of nickel and chromium in the remaining liquid.
Court papers noted that, by April 2010, the company had discovered 30 batches of its over-the-counter liquid remedies, including infants’ Tylenol, Children’s Tylenol and Children’s Motrin, that contained either some or all of the metal particles.
Eventually company officials traced the problem to a machine part manufactured from Waukesha 88, “a composite metal that is mostly nickel, but also includes iron, tin, bismuth and chromium,” said court documents quoted by the Inquirer.
The company said no sickness or injuries were reported from the incident. Reuters reported that the problem was discovered when “black specks” were seen by customers in the bottom of Infants’ Tylenol. The newswire service further reported that “moldy odors” and “labeling problems” were also found by government investigators.
$100 million in repairs to be made
Under law, McNeil was to have a written plan of action to document and correct the aforementioned problems, as well as additional measures in place to prevent future incidents. But according to the plea agreement, when an FDA inspector asked for the plan, a McNeil employee said there wasn’t one.
It was not until April 13, 2010, five days after its last discovery of tainted products, that the company halted production on one line. On April 30, acting with the FDA, McNeil issued a recall notice.
In addition to the children’s Tylenol and Motrin discussed in the plea agreement, McNeil also recalled Benadryl and Zyrtec products manufactured at the same Fort Washington facility.
The recent plea arrangement ended the criminal phase of a two-part process, the Inquirer said. J&J officials said initially the company would spend $100 million on upgrading and repairing the McNeil factory for future use. But before production can resume there, the FDA’s requirements must be met and the federal agency must certify that the fixes have been made and the plant is safe to operate. Then a federal court must also agree.
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