Early March of 2015, court documents were unsealed which said McNeil Consumer Healthcare, of Fort Washington, Pennsylvania, will acknowledge selling over-the-counter infant’s and children’s liquid medicine containing metal particles in their Infants’ and Children’s Tylenol, and Children’s Motrin and has agreed to pay $25 million to resolve the case. McNeil Consumer Healthcare is a subsidiary of Johnson & Johnson.
Metal particles, including nickel, iron and chromium, were introduced during the manufacturing process at McNeil’s plant in Fort Washington. McNeil acknowledged failing to take corrective action after discovering the adulterated bottles. Prosecutors said McNeil initially found out about the particle problem in May 2009, when a consumer complained about black specks inside a bottle of Infants’ Tylenol, according to court documents. McNeil issued a recall in April 2010. The Food and Drug Administration said the potential for serious medical problems was remote but advised consumers to stop using the medicine.
Even though McNeil subsequently found metal particles during production they continued making the liquid medicines for several more months. Company attorney Michael Schwartz told The Associated Press that, “There were investigative steps taken, but not all of the steps required under all of our internal operating procedures.”
Acting Assistant Attorney General Mizer said in a statement after the judge accepted McNeil’s plea that, “McNeil’s failure to comply with current good manufacturing practices is seriously troubling.” He also confirmed that, “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.”
McNeil is operating under an agreement with the FDA requiring increased inspections and oversight at its factories. Company spokeswoman Carol Goodrich said, “McNeil has been implementing enhanced quality and oversight standards across its entire business to ensure we are best able to meet our commitment to consumers, patients and doctors who rely on our products.”
Let’s hope so.