You might remember multiple recalls of over-the-counter medications from McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, at the beginning of this decade. These included adult and children’s versions of common drugs like Tylenol, Motrin, Zyrtec, and Benadryl. After settling criminal charges, now the company has now settled allegations that it marketed these products deceptively when claiming that it followed good manufacturing processes.
Failure to follow current good manufacturing practices for liquid children’s Tylenol, for example, led to McNeil distributing bottles of medicine to customers that had specks of nickel/chromium metal at the bottom.
In what we called the “Tylenol Recall Express” at the time in 2010 and 2011, products were recalled for metal specks, musty odors, not dissolving as quickly as they should, and just for being produced in a plant that was generally filthy and had poor quality control.
The company pleaded guilty to federal criminal charges related to the metal-laden children’s Tylenol in 2015, paying $25 million to the Food and Drug Administration. The problematic manufacturing facility in Pennsylvania remained closed from the time the FDA took control of it in 2011 until after the 2015 guilty plea.
This week, the company settled a deceptive marketing case with 42 states and the District of Columbia, but did not admit any wrongdoing. the governments will share a $33 million settlement from McNeil, and impose limits on how the company can advertise its products.
McNeil can’t claim that its facilities meet current Good Manufacturing Practices if its products have had Class I or Class II recalls through the Food and Drug Administration in the last 12 months. In a Class I recall, there is a “reasonable probability” that use of or exposure to a product may cause serious health problems or death. In a Class II recall, health consequences are temporary or reversible and not life-threatening.
The company must also follow its own internal procedures when manufacturing OTC drugs, fixing manufacturing issues before shipping out drugs, and must produce information about where any recalled drugs were distributed in their states within 60 days of a written request.
Products included in the recall were the adult and children’s versions of Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec, and Zyrtec Eye Drops.
“This is common sense,” Attorney General Eric Schneiderman of Consumerist’s home state of New York said in a statement sent this afternoon. “Over-the-counter drugs, especially those used to treat children, must be manufactured in accordance with federally mandated standards.”
Other attorneys general issued similar statements about their tolerance for marketing metal-laden or musty meds to the people of their states and districts.