PHILADELPHIA (CN) - After pleading guilty to stalling the recall of tainted children's medicines, Johnson & Johnson subsidiary McNeil-PPC owes $25 million.
The first contamination report came from a McNeil customer returned a bottle of Children's Tylenol in May 2009 because it contained "black specks," according to the government's information against the company.
Though lab tests showed that the product contained nickel and chromium, two materials that are not ingredients in the drug, McNeil failed to link the contamination to its manufacturing equipment, the U.S. government says.
Those metals are, however, part of the machinery McNeil used to manufacture children and infants' Tylenol and children's and infants' Motrin, at its plant in Fort Washington, Pa.
The government says McNeil did not implement a "Corrective Action Prevention Action," or CAPA, to address the contaminated medicine manufactured at its Fort Washington, Pa., plant until April 2010.
By that time, "McNeil itself [had] found particles in OTC liquid drugs during production at the Fort Washington plant" on three occasions, the plea agreement says, summarizing the allegations in the government's the information.
McNeil stopped production on one of its liquid lines after a fourth incident, on April 13, 2010, "when it found discolored OTC [over-the-counter] liquid drug product on the base of a liquid filler machine during production of Infants' Tylenol," the plea continues.
After the Food and Drug Administration uncovered various regulatory compliance failures that month, it helped McNeil institute a recall "all lots of certain unexpired infants' and children's OTC drugs manufactured at the Fort Washington plant," according to the plea.
All McNeil plants were placed under permanent injunction in 2011, and the Fort Washington plant where the incidents of contamination occurred remains closed.
The company is currently working to bring the plant into compliance.
In addition to a $20 million criminal fine, McNeil faces $5 million in criminal forfeiture.
McNeil has faced various civil lawsuits by consumers over the tainted medicine.