NEW YORK (TheStreet) -- J&J's (JNJ) - Get Report McNeil Consumer Healthcare division might face criminal enforcement action by the FDA over the reasons behind the unit's recent drug recalls, according to a report.
In testimony written by the FDA's principal deputy commissioner for a House committee hearing set for Thursday regarding McNeil's recent drug recalls -- which included children's Tylenol -- the agency said it's considering "additional enforcement actions against the company for its pattern of non-compliance which may include seizure, injunction or criminal penalties," the
Wall Street Journal
Photo Gallery J&J 2010 Medicine Recall
Principal deputy commissioner Joshua Sharfstein wrote that the FDA has been increasingly concerned about J&J's manufacturing process, according to
Prompting the recall was the discovery of a Tylenol raw ingredient that was contaminated by bacteria and greater-than-specified active ingredient in certain products. Certain products also contained residual metallic particulates.
There was no evidence that any of the contaminated material actually went into finished Tylenol products; but the FDA asserted that none of these problems should have occurred in the first place.
McNeil recently issued Children's Tylenol recalls and recalls of other products in the U.S., Canada, Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago and Kuwait.
Last December, the same division recalled all lots of Tylenol Arthritis Pain 100 count with EZ-Open Cap after receiving customer complaints about a strange odor emanating from the products.
Then, in January, the same division announced that it was recalling certain over-the-counter products in the Americas, United Arab Emirates and Fiji for the same reason.
-- Reported by Andrea Tse in New York
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