WASHINGTON, D. C. – District of Columbia Attorney General Karl A. Racine announced today that the District and 42 other states have reached a $33 million consumer settlement with Johnson & Johnson and Johnson & Johnson Consumer Inc. (collectively “Johnson & Johnson”) over adulterated versions of common over-the-counter (OTC) drugs. The settlement resolves allegations that, from 2009 through 2011, former Johnson & Johnson subsidiary McNeil-PPC, Inc. (“McNeil”) unlawfully sold adulterated versions of the drugs Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec, and Zyrtec Eye Drops and then failed to take adequate action to recall them.
“District residents deserve to know that the over-the-counter drugs they purchase meet robust safety standards,” said Attorney General Racine. “Any pharmaceutical company or any other company that defrauds consumers and risks their health and safety will be held accountable.”
The Attorney General’s complaint, filed today in the Superior Court of the District of Columbia in order to obtain court approval of the settlement, alleges that the sale and delayed recall of adulterated drugs violated District consumer protection laws by (1) misrepresenting the quality of the OTC drugs and (2) manufacturing, promoting, advertising, offering for sale, selling, and/or distributing OTC drugs that were deemed adulterated.
The settlement concludes a multistate investigation into McNeil’s marketing practices. The District and 11 states formed the investigation’s executive committee. The settlement agreement prohibits McNeil from:
Representing on its websites that its OTC drug product facilities meet good manufacturing practices outlined by the FDA if McNeil has had a Class I or Class II Recall of OTC drug products within the prior 12 months. Drugs are subject to Class I recalls if there is a reasonable probability that their use or exposure to the product will cause serious adverse health consequences or death. Class II recalls involve less serious situations where use of or exposure to the drug may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Failing to follow its internal standard operating polices regarding whether to open a corrective action/preventive action plan during the manufacture of an OTC drug.
Failing to provide information to participating state attorneys general within 60 days of a written request regarding the identity of wholesalers or warehouses to which any OTC drugs that were subject to a recall were distributed in their State.
District to Receive $615,223.06
The District, as one of the leaders of the investigation, is scheduled to receive $615,223.06 from the settlement. Today’s settlement was also joined by Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington state, West Virginia, and Wisconsin.
If you have a complaint about a pharmaceutical product or any other consumer problem, call the Office of the Attorney General Consumer Protection Hotline at (202) 442-9828 or send an email to our Office of Consumer Protection at consumer.protection@dc.gov. You can also submit a complaint via our online form (available in English and Spanish) here.