CNN is reporting that the FDA has referred the Tylenol recall case to their criminal division for investigation. At issue is a pattern of non-compliance with FDA warnings and failures by management of McNeil to investigate and provide a timely resolution to serious problems with the product. These problems include excess amounts of the active ingredient in Tylenol, acetaminophen.
At a House hearing today the Food and Drug Administration discussed “significant violations” of manufacturing regulations by McNeil Consumer Healthcare, says CNN.
During the hearing Rep. Darrell Issa, R-CA, asked a FDA official whether there was criminal liability as a result of the recalls.
“Well, it has been referred to the FDA’s crime division,” said Deborah Autor, a director at the FDA’s compliance office.
“I’m going to take that as a yes, that there are potential criminal charges and indictments,” Issa responded.
The FDA is currently investigating 775 reports of serious side effects from recalled McNeil products.