AG Balderas Announces $453,000 Settlement with Johnson & Johnson Concerning the Quality of Over-The-Counter Drugs


Contact: James Hallinan (505) 660-2216

Drugs involved include Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec and Zyrtec Eye Drops

Santa Fe, NM – This morning, Attorney General Hector Balderas announced that New Mexico will receive $453,474.16 from a settlement with Johnson & Johnson concerning their representations regarding the quality of over-the-counter drugs. Attorney General Balderas and 42 other attorneys general reached a $33 million settlement with Johnson & Johnson Consumer Inc. and Johnson & Johnson (“Defendants”). McNeil-PPC, Inc. was a wholly-owned subsidiary of Johnson & Johnson that manufactured and distributed over-the-counter (OTC) drugs.

“All New Mexicans deserve access to quality, affordable healthcare, and that includes the over-the-counter medications our children and families rely on every day for their health,” said Attorney General Balderas. “I will hold corporations who put profits over patients accountable, and I am pleased that we secured over $450,000 for New Mexico taxpayers in this time of financial crisis.”

The settlement resolves allegations that 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 from 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 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; Class I recalls involve situations in which there is a 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 is 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 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.

Also participating in the settlement are Alaska, Arkansas, California, Colorado, Connecticut, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, Washington, West Virginia, and Wisconsin.

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