New HampshireDepartment of JusticeOffice of the Attorney General

News Release

For Immediate Release
May 24, 2017

James T. Boffetti, Senior Assistant Attorney General
Chief, Consumer Protection Bureau
(603) 271-0302

New Hampshire joins 42 other States in reaching $33M consumer settlement with Johnson & Johnson Consumer, Inc. and Johnson & Johnson concerning their representations regarding the quality of over-the-counter drugs

Attorney General Gordon J. MacDonald has announced that New Hampshire has joined a settlement with Johnson & Johnson Consumer, Inc. and Johnson & Johnson related to its marketing of certain over-the-counter (OTC) drugs. Those drugs were marketed through McNeil Consumer Healthcare Division (McNeil), formerly a division of McNeil-PPC. Inc. McNeil is now a division of Johnson & Johnson Consumer, Inc. The settlement resolves allegations that the Defendants, acting through McNeil, unlawfully promoted their OTC drugs as complying with federally mandated current Good Manufacturing Practices (cGMP) even though the FDA found that some McNeil manufacturing facilities did not comply with cGMPs between 2009 and 2011. Moreover, some McNeil OTC drugs were deemed adulterated as a matter of federal law.

The Complaint filed today, alleges the Defendants acting through McNeil violated state consumer protection laws by (1) misrepresenting the cGMP compliance and the quality of their OTC drugs and (2) representing that these OTC drugs had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities or qualities that they did not have. According to the complaint, McNeil delivered for introduction into state commerce certain batches of OTC drugs that failed to comply with federal standards, and as such, were deemed adulterated. McNeil's alleged quality control lapses resulted in recalls of drugs manufactured between 2009 to 2011 including Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec and Zyrtec Eye Drops several of which are indicated for pediatric use.

The Consent Judgment, filed at the same time as the Complaint, requires McNeil to ensure that its marketing and promotional practices do not unlawfully promote OTC drug products. Specifically, McNeil shall not:

Represent on its websites that McNeil's OTC Drug Product facilities meet cGMP asoutlined by the FDA if McNeil has had a Class I or Class II Recall of OTC drug products within the prior twelve (12) months; Class I recalls involve situations in which there are reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recalls involve situations in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences are remote;

Fail to follow its internal standard operating polices regarding whether to open a Corrective Action/Preventive Action plan (CAPA) during the manufacture of an OTC drug; and

Fail to provide information to participating Attorneys General within sixty (60) days of awritten request regarding the identity of wholesalers or warehouses to which any OTC drugs that were subject to a recall were distributed in their State.

In addition to the injunctive terms, the settlement requires the Defendants to make a payment of $33M to the participating states. New Hampshire's portion of the settlement funds will be $414,136.72.

New Hampshire Department of Justice
1 Granite Place South | Concord, NH | 03301
Telephone: 603-271-3658