McNeil charged with OTC drug violations

March 22, 2011

McNeil-PPC must cease manufacturing and distributing and destroy all drugs under its control that were recalled from the Fort Washington, Pa.; Las Piedras, Puerto Rico; and Lancaster, Pa., facilities since December 2009, according to a consent decree from the Department of Justice.

A recently filed consent decree of permanent injunction by the U.S. Department of Justice's Office of Consumer Litigation and the U.S. Attorney's Office for the Eastern District of Pennsylvania against McNeil-PPC and 2 of its officers requires the company to destroy all drugs under its control that were recalled from the Fort Washington, Pa.; Las Piedras, Puerto Rico; and Lancaster, Pa., facilities since December 2009.

The consent decree also prevents McNeil, a subsidiary of Johnson & Johnson, from manufacturing and distributing drugs from the 3 facilities, according to FDA. "This FDA drug safety enforcement action is aimed at protecting the public health," said Dara A. Corrigan, the FDA's associate commissioner for regulatory affairs.

From 2009 to 2010, FDA inspections found violations of the Federal Food, Drug, and Safety Act at McNeil's Fort Washington, Las Piedras, and Lancaster facilities. Manufacturing deficiencies resulted in several extensive recalls at McNeil's facilities, including an April 30, 2010, recall of lots of several liquid products such as children's Tylenol, Motrin, Zyrtec, and Benadryl products.

Under the decree, McNeil must retain an independent expert to inspect the 3 facilities to determine whether violations have been corrected and to ensure that adequate manufacturing processes are in place. FDA will determine whether the facilities are in compliance after expert certification.

McNeil faces substantial penalties for violating the decree, including the possibility of an FDA order to cease manufacturing and recall products. FDA could also levy fines of $15,000 for each day the company is in violation of the decree and an additional $15,000 for each violation of the law, up to $10 million annually.

"This is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity," said Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research.