Johnson & Johnson has agreed to pay $33 million to settle charges that some of its over-the-counter drugs didn’t meet federal standards. The case was brought by 42 states and the District of Columbia.
Between 2009 and 2011, McNeil-PPC, Inc.—then a wholly-owned subsidiary of Johnson & Johnson—manufactured and distributed OTC drugs that purported to comply with federally mandated current Good Manufacturing Practices (“cGMP”). However, an investigation conducted by the FDA and Attorneys General across the country revealed that a number of McNeil manufacturing facilities and the medications they produced did not meet the national cGMP standards.
The investigation’s findings resulted in the recall of several adulterated McNeil drugs that were initially introduced to the market in batches. The recalled medication included Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec, and Zyrtec Eye Drops—several of which are indicated for pediatric use.
“This is common sense: over-the-counter drugs, especially those used to treat children, must be manufactured in accordance with federally mandated standards,” said New York Attorney General Eric T. Schneiderman. “Drug companies that use deceptive practices threaten New Yorkers’ health and wellbeing – and we won’t hesitate to hold them accountable.”
In addition to the monetary penalties, the consent judgment requires McNeil to reform its marketing and promotional practices. Under the terms of the agreement, McNeil must not:
- Advertise on its websites that McNeil’s OTC drug product facilities meet cGMP if the drug has had a Class I or Class II recall within the previous 12 months. Class I recalls involve a reasonable probability that use or exposure to the drug may result in serious detrimental health consequences or death. Class II recalls involve potential temporary or reversible health consequences or where potential adverse health consequences are unlikely.
- Fail to follow internal operating procedures regarding whether to take corrective or preventive action for OTC drugs during the manufacture of an OTC drug; and
- Fail to identify or provide information to participating Attorneys General within 60 days of a written request about vendors or warehouses in which recalled OTC drugs were distributed in their state.
The following states participated in the settlement: 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, Virginia, Washington, West Virginia, and Wisconsin.