J&J's McNeil Pleads Guilty Over Children's Tylenol Recall; To Pay $25 Mln

(RTTNews) - McNeil-PPC Inc, a wholly owned subsidiary of Johnson & Johnson (JNJ), entered a guilty plea in Federal District Court in Philadelphia today to one count of an information charging the company with delivering for introduction into interstate commerce adulterated infants' and children's over-the-counter or OTC liquid medicines, the U.S. Department of Justice announced.

As part of the criminal resolution, McNeil agreed to pay a criminal fine of $20 million and forfeit $5 million.

According to the criminal charge, the infants' and children's liquid medicines were adulterated because they were not manufactured, processed, packed or held in conformance with current Good Manufacturing Practices (cGMP), in violation of the federal Food, Drug and Cosmetic Act (FDCA).

The U.S. District Court for the Eastern District of Pennsylvania accepted McNeil's guilty plea.

In addition to McNeil's guilty plea, McNeil remains subject to a permanent injunction entered by the U.S. District Court in 2011, requiring the company, among other things, to make remedial measures before reopening its manufacturing facility in Fort Washington, Pennsylvania.

According to the information, the OTC liquid drugs manufactured by McNeil at its Fort Washington facility, including Infants' and Children's Tylenol and Infants' and Children's Motrin, were bottled on four lines of machinery dedicated to liquid formulations. As alleged in the information, on or about May 1, 2009, McNeil received a complaint from a consumer regarding the presence of "black specks in the liquid on the bottom of the bottle" of Infants' Tylenol.