$33 million settlement over misreprentation of OTC drugs’ quality

Illinois Attorney General Lisa Madigan and 42 other attorneys general recently announced they have reached a $33 million settlement with Johnson & Johnson and its subsidiary over misrepresentations it made about manufacturing practices of well-known, over-the-counter, OTC, drugs.

The practices resulted in recalls of products manufactured between 2009 and 2011, including children’s medicines.

McNeil-PPC Inc., a wholly-owned subsidiary of Johnson & Johnson that manufactured the OTC drugs between 2009 and 2011 and which is now a part of Johnson & Johnson Consumer Inc., represented that it complied with federal Good Manufacturing Practices, cGMP, even though the Federal Drug Administration, FDA, found that some McNeil manufacturing facilities did not comply between 2009 and 2011. 

This meant some of the OTC drugs were not manufactured, processed, packed or held in conformance with the cGMP mandates. 

In addition, between May 2009 and April 2010, there were reports of foreign material, particulate matter or contamination in some of the OTC drugs. 

The company’s alleged quality control lapses led to the recall of many common medications, including Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec and Zyrtec Eye Drops.

The settlement agreement requires Johnson & Johnson Consumer Inc. to ensure that its marketing and promotional practices do not unlawfully promote OTC drug products.