McNeil-PPC, Inc., a subsidiary of pharma giant Johnson & Johnson, pleaded guilty on March 10, 2015 for violating the federal 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 has pleaded guilty to a federal misdemeanor charge and will pay a $20 million fine. Additionally, they have been ordered to pay another $5 million for allowing Infants’ Tylenol, Children’s Tylenol and Children’s Motrin products into the market that were tainted with metals.
Click here to read the full article: J&J pleads guilty, pays $25M tied to metal-tainted Children’s Tylenol
The complaint stems when on May 1, 2009, a complaint was received by McNeil by concerned consumer regarding the presence of “black specks in the liquid on the bottom of the bottle” of Infants’ Tylenol, which originating from its Fort Washington facility in Pennsylvania. According to FDA documents, instead of initiating an investigation into this matter, Johnson & Johnson opted to do nothing – failing to complete or initiate a CAPA. Court records indicate that the particles were later determined to be “nickel/chromium-rich inclusions”. These particles are not ingredients that should have been in the products taken by children throughout the world,
FDA Commissioner Margaret Hamburg said: “Drug quality–and especially with the medicines we give our children–is of paramount concern to the FDA. … 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.”
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