J&J Pleads Guilty to Selling Liquid Medicine Contaminated with Metal
Description of the Case
According to Reuters, McNeil Consumer Healthcare acknowledged producing contaminated bottles of Infants’ and Children’s Tylenol and Children’s Motrin. The company agreed to pay $25 million to resolve the case.
Metal particles, including nickel, iron and chromium, were introduced during the manufacturing process back in 2009 and 2010. The particle problem was first discovered in May 2009, when a consumer complained about unusual black specks inside a bottle of Infants' Tylenol.
The drugs were subsequently recalled in April 2010. No injuries have been reported. Prosecutors accused the company of continuing to profit off of the tainted medications for nearly a year, and also made claims that McNeil failed to take immediate action to remedy the situation.
FDA Investigation and Closing of the Fort Washington Plant
A Food and Drug Administration investigation found that the Fort Washington plant producing the medication contained bacteria in raw materials, poor quality controls, and general sanitation issues.
The suburban Philadelphia location was shutdown in April 2010, and rebuilt from the ground up, but has yet to re-open its doors. The closing of the factory caused supply disruptions for several of McNeil’s over-the-counter drugs. Johnson & Johnson has been forced to recall a variety of pharmaceutical products since 2009. McNeil was not the only subsidiary that had quality-control issues during that time period.
Additionally as part of the settlement, McNeil Consumer Healthcare has agreed that further and more stringent safety measures must be put in place before the Fort Washington plant re-opens.