Over-the-Counter Drug Noncompliance with Good Manufacturing Practices
Forty-two states and the District of Columbia reached a $33 million settlement with Johnson & Johnson over allegations that the company’s over-the-counter drugs didn’t comply with federal manufacturing standards. The lawsuits alleged that J&J’s McNeil PPC subsidiary promoted their drugs as complying with federal good manufacturing practices, even though the U.S. Food and Drug Administration found that some of the company’s manufacturing facilities were out of compliance between 2009 and 2011. The alleged compliance issues resulted in the recall of products including Tylenol, Motrin, Benadryl, St. Joseph aspirin, Sudafed, Pepcid, Mylanta, Rolaids, and Zyrtec.
- Misconduct Type
- Enforcement Agency
- Contracting Party
- Court Type
- Date of Settlement Announcement
|Johnson & Johnson||$33,000,000|