The U.S. Department of Justice announced that McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, pleaded guilty to selling children's versions of over-the-counter medications such as Tylenol and Motrin that contained contaminants including nickel and chromium particles. The company also agreed to pay $25 million to settle the case and improve safety measures before reopening its manufacturing facility in Fort Washington, Pa.
Johnson & Johnson alleges that a Pfizer ad for children's Advil that ran in medical journals violated a 1989 court order barring claims that products are like or comparable to children's Tylenol. J&J filed a cease-and-desist letter, and Pfizer responded with a lawsuit contending that J&J is improperly attempting to expand the scope of the court order and is depriving doctors and consumers of useful, truthful information.
Johnson & Johnson and its McNeil PPC unit are facing a lawsuit filed by parents of Markus Cherry, a 3-month-old baby who died three days after taking Tylenol Infants' Drops in 2010. According to the FDA, bacterial contamination prompted McNeil to withdraw the product from the market two weeks after the infant's death.
Johnson & Johnson's McNeil Consumer Healthcare withdrew four batches of Benadryl allergy tablets and one lot of Extra Strength Tylenol gels that were "inadvertently omitted" from a recall in January. That recall involved medicines reportedly contaminated with the chemical 2,4,6-tribromoanisole. In April, McNeil recalled 40 types of children's drugs.
Johnson & Johnson's McNeil Consumer Healthcare unit did not test Tylenol for chemical contaminants or conduct a formal investigation after receiving complaints in 2008 that the pain drug had a musty odor and might have caused gastrointestinal problems, FDA inspectors reported. A representative of McNeil said the company is "actively working" with the agency to resolve the issue.