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 is turning its McNeil Consumer Healthcare unit into a separate organization to focus on improving "quality and compliance, and the critical task of restoring" over-the-counter brands affected by a string of recalls. The remaining divisions of J&J's consumer group will be reorganized into four regions, including North America and Asia-Pacific. The changes will take effect Monday.
Bayer filed for European approval of anticoagulant Xarelto, or rivaroxaban, to prevent stroke in patients with atrial fibrillation. Meanwhile, partner Johnson & Johnson filed a marketing application with the FDA for the same indication. J&J also submitted additional data to the FDA concerning Xarelto's use after major orthopedic surgery.
Johnson & Johnson units Ortho-McNeil-Janssen Pharmaceuticals and Ortho-McNeil Pharmaceutical will settle criminal and civil allegations regarding off-label promotion of epilepsy drug Topamax by paying more than $81 million. Ortho-McNeil, which entered a guilty plea, "voluntarily discontinued the program at issue before receiving the government's first subpoena in the investigation," Ortho-McNeil-Janssen said.
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.