McNeil Pleads Guilty, Accepts $20 Million Criminal Fine, for Contaminated Children’s Medicines By Tod Aronovitz | 03/23/15 | 0 Comment

McNeil-PPC Inc., a wholly owned subsidiary of Johnson & Johnson, entered a guilty plea in Federal District Court in Philadelphia as a result of its production of contaminated infants’ and children’s over-the-counter liquid drugs, the U.S. Department of Justice announced. McNeil also agreed to pay a $20 million criminal fine and forfeit $5 million.

According to case documents against McNeil, the medicines were adulterated because they were not manufactured, processed, packed or held in conformation with current Good Manufacturing Practices (CGMP), in violation of the federal Food, Drug and Cosmetic Act (FDCA).

The OTC liquid drugs in question—including Infants’ and Children’s Tylenol and Infants’ and Children’s Motrin—were manufactured at McNeil’s Fort Washington, Pennsylvania, facility on four lines of machinery dedicated to liquid formulations. Allegedly, on or about May 1, 2009, McNeil received a consumer complaint about the presence of “black specks in the liquid on the bottom of the bottle” of Infants’ Tylenol. The foreign matter was later identified as nickel/chromium-rich inclusions, which were not intended ingredients.

McNeil should have initiated or completed a Corrective Action Preventive Action (CAPA) as a result of these findings, according to case records, but apparently did not. The information brought forth in this case alleges other instances when the Fort Washington facility found metal particulates in the Infants’ Tylenol it produced, but also failed to complete a CAPA.

During an inspection in 2010, the FDA requested a list of all non-conformance particles in the associated drug batches that had occurred since 2009. McNeil turned over that list, which cataloged 30 batches of OTC liquid drugs including Infants’ Tylenol, Children’s Tylenol, and Children’s Motrin, but could not supply any CAPA plans because they supposedly did not exist.

As a result, around April 30, 2010, McNeil’s Consumer Health Care division, in conjunction with the FDA, recalled all lots of certain expired Infants’ and Children’s OTC drugs made at the Fort Washington facility and distributed in the United States and to other countries.

According to Miami personal injury attorney Tod Aronovitz, these regulations have been put in place to protect consumers from potentially lethal outcomes. The Food, Drug and Cosmetic Act (FDCA) considers a drug 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.

This act also prohibits causing the introduction of or delivery for introduction into interstate commerce of any adulterated drug. Under federal law, drugs not in compliance with CGMP are considered adulterated even if they don’t show any actual defect.

“Drug quality–and especially with the medicines we give our children–is of paramount concern to the FDA,” said Commissioner Margaret A. Hamburg M.D. of the FDA. “The FDA expects manufacturers to have systems in place that will quickly discover and correct problems with medical products before they enter the U.S. marketplace. Today’s guilty plea holds accountable those corporations who risk jeopardizing the public health by not adhering to the high standards set for drug manufacturers.”

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

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