The drugs include Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec and Zyrtec Eye Drops – all manufactured and distributed by McNeil Consumer Healthcare Division, which is now a division of Johnson & Johnson Consumer Inc., a wholly owned subsidiary of Johnson & Johnson.
The multimillion-dollar settlement reached by a group of state attorneys general and Johnson & Johnson, and submitted to Franklin Circuit Court on Wednesday, resolves allegations that McNeil promoted these drugs as complying with federally mandated manufacturing standards even though the U.S. Food and Drug Administration found that some of its manufacturing facilities were not in compliance with federal standards between 2009 and 2011.
“Through this settlement we are once again holding a drug company accountable for not only violating Kentucky’s consumer protection laws but for placing our families and children at risk by not following federal manufacturing safety standards,” Beshear said. “The judgment we are announcing today is an important step toward ensuring the safe manufacture and lawful marketing and promotion of over-the-counter drugs to all Kentuckians.”
The company’s alleged quality control lapses resulted in recalls of many of its drugs manufactured between 2009 to 2011 including several used for pediatric or infant use. Failure of a company to comply with FDA standards may result in bacterial or foreign body contamination of a drug, or super-potent or ineffective medicines.
Beshear said Kentucky served on the executive committee on the multistate lawsuit that involved 42 states and the District of Columbia. Neighboring states joining in the settlement include Illinois, Indiana, Ohio, Tennessee, Virginia, and West Virginia.
