The maker of Children’s Tylenol pleaded guilty Tuesday, March 10, to a federal criminal charge of selling over-the-counter liquid medicine contaminated with metal particles.
McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson that manufactures Infants’ and Children’s Tylenol and Children’s Motrin, acknowledged it failed to take corrective action after discovering the adulterated bottles, The New York Times reported. The company agreed to pay $25 million to settle the case.
The company said it knew about the metal particles found in the medicine, including chromium, iron and nickel, for about a year but did not immediately work toward fixing it.
“McNeil’s failure to comply with current good manufacturing practices is seriously troubling,” Acting Assistant Attorney General Mizer said in a statement following the judge’s acceptance of McNeil’s plea.
“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,” he said.
The introduction of metal particles were traced to the subsidiary’s plant in Fort Washington, Penn. It first learned about the particle problem in May 2009 when a consumer complained of black specks in a bottle of Infants’ Tylenol, according to court documents. McNeil discovered metal particles in subsequent production but continued manufacturing the liquid medicine for several more months.
“The particles may be solidified product ingredients or manufacturing residue such as tiny metal specks,” said Marc Boston, a McNeil spokesman, according to a 2010 New York Times report.
The company and prosecutors said Tuesday that nobody was injured. However, in late 2009, the 4-year-old son of New York resident Shawn Arndt died after taking one dose of Infant’s Tylenol. Arndt sued the company in 2012. His suit was dismissed by the US District Court for Eastern Pennsylvania in December 2014, partly because his son died in November 2009, several months after the recall was issued.
The McNeil plant in Philadelphia was closed in April 2010 and rebuilt from the ground up, but has not yet re-opened. The company is currently operating under an agreement with the FDA requiring more inspections and oversight at its factories, the Times reported.
On Tuesday, the company said it has significantly enhanced its procedures.
“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,” said company spokeswoman Carol Goodrich.
(With reports from Associated Press, Reuters, RT and The New York Times)
(www.asianjournal.com)
(LA Weekend March 14-17, 2015 Sec. A pg.9)
