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McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.
McNeil-PPC Inc., a wholly owned subsidiary of Johnson & Johnson, pleaded guilty on March 10 to violating the Food, Drug and Cosmetic Act (FDCA) with regard to infants’ and children’s liquid medications, including Infants’ Tylenol, Children’s Tylenol, and Children’s Motrin. The company was charged with delivery for introduction into interstate commerce drugs that were deemed adulterated, a misdemeanor, and will pay a criminal fine of $20 million and forfeit $5 million.
The guilty plea and resolution were announced by the US Department of Justice (DOJ).
According to court documents, the over-the-counter (OTC) liquid drugs manufactured by McNeil at its Fort Washington, PA facility 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 later identified as including nickel/chromium-rich inclusions, which were not intended ingredients in the liquid drug. The DOJ reports that McNeil did not initiate or complete a corrective action preventive action (CAPA) plan in conformance with current GMPs.
The DOJ, in a statement, reports information that alleges 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 that facility, 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 a recall of all lots of certain unexpired Infants’ and Children’s OTC drugs manufactured at the Fort Washington facility and distributed in the United States and other countries.
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, according to a DOJ press statement.
McNeil remains under a 2011 permanent injunction entered by the US District Court in the Eastern District of Pennsylvania, requiring it to make remedial measures before reopening its Fort Washington facility, DOJ reports.
Source: US Department of Justice