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.

From CNN:

“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.

Tylenol recalls referred to FDA crime division [CNNMoney]

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