Children’s Tylenol Recall
In a lawsuit filed in Philadelphia, Daniel and Katy Moore of Ellensburg, Washington claimed that their son received a larger dose of acetaminophen than normal, which caused liver damage and ultimately was fatal to their two-year-old. These parents sued Tylenol’s manufacturer, Johnson & Johnson and its subsidiary, McNeil Consumer Healthcare. The Moore’s son died on July 23, 2010, the Philadelphia Inquirer reported.
Earlier in 2010, the FDA had recalled 43 varieties of Children’s Tylenol. Some of the recalled products included Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles and Children’s Benadryl Allergy Liquid. These medications were recalled in the US and 11 other countries because it was believed that some of the drugs contained a higher concentration of active ingredients that was specified. Some also contained tiny particles of metal and others held musty-smelling pills. The manufacturer recalled more that 136 million bottles of infants’ and childrens’ products.
These defective drugs had been linked to hundreds of serious illnesses and 30 deaths. Johnson & Johnson sent a letter to physicians and poison control centers that informed professionals about the recall. In the letter, J&J stated that some of the defective samples contained 24 percent more active ingredient than was required. This recall went down in history as the largest involving children’s medicines—nearly 70 percent of over-the-counter pediatric liquid medicines.
The FDA had received 775 complaints related to the use of the medications from 2008 through 2010. After the recall, the agency continued getting adverse reports and there were seven more deaths reported. The FDA began to investigate the manufacturing procedures at a plant in Fort Washington, PA, where these medicines were made. There was also an investigation into the processes of McNeil Consumer Healthcare, and the FDA looked into other plants in Lancaster, PA and Pideras, Puerto Rico.
During the inspection at the Fort Washington, PA plant, more than 20 manufacturing problems were identified, which included the lack of proper testing for contaminated products. The FDA placed the blame on McNeil for failing to correct issues, even after receiving 46 consumer complaints regarding foreign materials in the drugs. McNeil was also charged with knowingly using contaminated materials to make the recalled drugs.