Children's Tylenol Maker Pleads Guilty to Selling Tainted Medicine
A manufacturer of Infants' and Children's Tylenol and Children's Motrin has pleaded guilty to selling liquid medicine tainted by metal particles. McNeil Consumer Healthcare admitted some batches of over-the-counter medicine contained nickel, iron, and chromium particles.
While both prosecutors and the company said no one was injured by the contaminated medicine, McNeil will nonetheless pay $25 million as part of the plea agreement.
Prosecutors allege that McNeil knew about the problem at its Fort Washington, Pennsylvania, plant for nearly a year but failed to make immediate changes.
A subsidiary of Johnson & Johnson, McNeil first learned about the contamination when a consumer complained in 2009. Despite discovering metal particles being introduced to the medicine during production, McNeil continued making the medicine for several months.
As McNeil's attorney Michael Schwartz told The Associated Press, "There were investigative steps taken, but not all of the steps required under all of our internal operating procedures." The company contends it has been implementing more stringent oversight and quality control standards at all of its facilities.
This was not the first problem at McNeil's plant in suburban Philadelphia. The AP reported that the site was closed in 2010 after being linked to several recalls involving Tylenol and other drugs. The plant has been rebuilt, but has yet to reopen.
The company is currently subject to increased inspection and oversight by the FDA.
This is also not the first problem for Johnson & Johnson and McNeil. The pair were sued in 2012 after a child died, allegedly because of contaminated Tylenol Infant Drops. And a different family was awarded $63 million in 2013 when their daughter suffered severe side effects from Children's Motrin.
As noted above, it appears that no children were harmed by the contaminated medicine in this case, although McNeil issued a recall in 2010 and the FDA advised consumers to stop taking the medicine.