McNeil-PPC Inc. pled guilty to one count of an information charging the company with delivering for introduction into interstate commerce adulterated infants’ and children’s over-the-counter (OTC) liquid medicines.  

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

McNeil was represented by Thomas Gallagher and Michael Schwartz of Pepper Hamilton in Washington and by Ethan Posner and Christopher Denig of Covington & Burling in Washington.

A criminal Information was filed against McNeil in federal court in Philadelphia for delivering for introduction into interstate commerce infants’ and children’s liquid OTC drugs that were adulterated.

Federal officials alleged that 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).

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.

“McNeil’s failure to comply with current good manufacturing practices is seriously troubling,” said Acting Assistant Attorney General Benjamin Mizer.  “The Department of Justice will continue to be aggressive in pursuing and punishing companies such as McNeil that disregard a process designed to assure quality medicines, especially OTC drugs for infants and children.”

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.  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.  The foreign material was later identified as including nickel/chromium-rich inclusions, which were not intended ingredients in this OTC liquid drug.

In connection with receiving this consumer complaint, McNeil did not initiate or complete a Corrective Action Preventive Action (CAPA) plan, as alleged in the charging document.

The information alleges numerous other instances in which McNeil found metal particles in bottles of Infants’ Tylenol at its Fort Washington facility but failed to initiate or complete a CAPA.

During a 2010 Inspection of McNeil’s Fort Washington facility, the U.S. Food and Drug Administration (FDA) asked McNeil for a list with all non-conformances for particles and the associated OTC drug batches that had occurred since an FDA inspection in 2009.

This document revealed 30 batches of OTC liquid drugs, including Infants’ Tylenol, Children’s Tylenol, and Children’s Motrin.

During the 2010 inspection, the FDA asked McNeil for the CAPA plan covering the particles and foreign material found in the Infants’ and Children’s OTC drugs, and a McNeil employee confirmed that McNeil did not have such a CAPA plan.

On or about April 30, 2010, McNeil Consumer Health Care, a division of McNeil, in consultation with the FDA, announced that the company was recalling all lots of certain unexpired Infants’ and Children’s OTC drugs manufactured at McNeil’s Fort Washington facility and distributed in the United States and other countries around the world.

McNeil’s recall included, but was not limited to, Infants’ and Children’s Tylenol and Infants’ and Children’s Motrin.  According to a press release issued by McNeil on April 30, 2010, some of the recalled OTC drugs “may contain tiny particles.”

The FDCA prohibits causing the introduction or delivery for introduction into interstate commerce of any adulterated drug.  Under the law, a drug is adulterated if the methods used in, or the facilities and controls used for, the manufacture, processing, packing, labeling, holding and distribution of drugs and components were not in conformance with cGMP requirements for drugs.

Drugs not manufactured, processed, packed, labeled, held and distributed in conformance with cGMP requirements are adulterated as a matter of federal law, without any showing of actual defect.