Children’s Tylenol maker McNeil Consumer Healthcare pleaded guilty recently to a federal criminal charge that the company knowingly sold infants’ and children’s medicine containing metal particles. The Johnson & Johnson subsidiary admitted that it was aware of the manufacturing problem for almost a year before taking corrective action. This latest Tylenol case calls to mind the drug recalls and scares of the 1980’s, which included lethal tampering with Tylenol and later copycat tampering with Excedrin in Washington.
In this case, McNeil acknowledged that particles of nickel, iron, and chromium were introduced into liquid infants’ and children’s Tylenol and children’s Motrin during manufacturing at their plant near Philadelphia. Although the particles did not cause injury, the FDA advised families to stop using adulterated medicines.
An attorney for McNeil acknowledged that although the company launched an initial investigation of the problem after a consumer reported it in 2009, it did not follow through on all of the steps required in its own internal guidelines. The plant, which was linked to other Tylenol recalls, was closed in 2010 and completely rebuilt, though it has not yet reopened. Department of Justice prosecutors faulted McNeil for not following good manufacturing practices and promised continued aggressive oversight and punishment of any companies that disregard these practices and safeguards, particularly when the health of children is at stake.