Jason S. Miyares
Attorney General of Virginia

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Commonwealth of Virginia
Office of the Attorney General

Mark Herring
Attorney General

202 North Ninth Street
Richmond, Virginia 23219


For media inquiries only, contact:  
Lara Sisselman, Press Secretary
Phone: (804)786-5874 
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~Virginia to receive approximately $770,000 in settlement concerning representations about quality of over-the-counter drugs~

RICHMOND (May 25, 2017) -- Attorney General Mark R. Herring today announced that the Commonwealth of Virginia has joined 41 other states and the District of Columbia in a $33 million settlement with Johnson & Johnson Consumer Inc. and Johnson & Johnson concerning the conduct of its wholly-owned subsidiary, McNeil-PPC, Inc. ("McNeil") in the marketing, promotion, and distribution of certain over-the-counter ("OTC") drugs. Virginia will receive approximately $777,000 of the settlement.


The Complaint, filed today in Richmond Circuit Court, alleges that McNeil violated state consumer protection laws by misrepresenting the contents and quality of their OTC drugs, and these drugs' compliance with current Good Manufacturing Practices (cGMP). According to the complaint, McNeil delivered 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.


"Drug companies that market and distribute adulterated medications are not only deceiving their consumers, but they're also jeopardizing their health, and that is both reckless and dangerous," said Attorney General Mark Herring. "This settlement sends a message to drug companies in the Commonwealth and around the country that such lapses in quality control, and any efforts to conceal that information from consumers, will not be tolerated."


The settlement resolves allegations that Johnson & Johnson, acting through McNeil, unlawfully promoted their OTC drugs as complying with federally mandated cGMPs, 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 Consent Judgment 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 as outlined by the FDA if McNeil has had a Class I or Class II Recall of OTC drug products within the prior twelve (12) months;
  • 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 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.

The settlement, which is in the form of a consent judgment, has been filed with the Circuit Court for the City of Richmond for approval. 

Also participating in the settlement are Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, 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, Washington, West Virginia, and Wisconsin.


This matter is being handled by Attorney General Herring's Consumer Protection Section. In November, Attorney General Herring announced the completion of a reorganization of the OAG Consumer Protection Section to more efficiently and effectively enforce Virginia's consumer protection laws, provide exceptional customer service in resolving complaints and disputes, and provide robust consumer education to keep Virginians from being victimized by fraud, scams, or illegal or abusive business practices. During Attorney General Herring's administration the OAG Consumer Protection Section has recovered more than $200 million in relief for consumers and payments from violators.


If you have any consumer-related inquiries, the Office of the Attorney General's Consumer Protection Hotline telephone counselors are available to assist you with your consumer questions.  Please call the Consumer Protection Hotline at 1-800-552-9963 if calling from Virginia, or 804-786-2042 if calling from the Richmond area. You can also subscribe to the Consumer Protection Quarterly Newsletter here