McNeil Consumer Healthcare is expanding its recall of several over-the-counter medications following an investigation into complaints that some products had a moldy smell and caused temporary gastrointestinal symptoms.
In a Jan. 15 press conference to announce the expanded recall, U.S. Food and Drug Administration officials called McNeil to task for acting too slowly.
The voluntary recall affects certain lots of products: Children’s Motrin, Children’s Tylenol, Benadryl, Extra Strength Tylenol, Motrin IB, Regular Strength Tylenol, Rolaids, Simply Sleep, St. Joseph Aspirin, Tylenol 8 Hour, Tylenol Arthritis, and Tylenol PM. McNeil has posted a full list of the affected products and their lot numbers on its Web site (www.mcneilproductrecall.com). The recall affects products sold in the Americas, the United Arab Emirates, and Fiji.
The company is advising consumers who purchased products from among the recalled lots to stop using the product and contact McNeil for instructions on a refund or replacement.
This expanded recall comes after McNeil Consumer Healthcare recalled all lots of Tylenol Arthritis Pain 100 count with EZ-OPEN CAP in December 2009.
The recalls are based on consumer complaints going back to 2008 that some McNeil OTC products had an unusual moldy, musty, or mildewlike odor. The company also received complaints from consumers who temporarily became ill after taking the products. The most common symptoms reported were nausea, stomach pain, vomiting, and diarrhea.
After an investigation, the company concluded that the smell was caused by trace amounts of the chemical 2,4,6-tribromoanisole (TBA), which is used in treating the wood pallets used to transport and store product packaging materials. While the health effects of the chemical have not been well studied, officials at the FDA said no serious effects have been documented in the medical literature and so far all of the adverse events reported have been minor.
During the press conference, Deborah M. Autor, director of the Office of Compliance at the FDA Center for Drug Evaluation and Research, said McNeil became aware of the problem in September 2008 but failed to report it to the FDA for a full year. The company’s initial investigation was also too limited, according to the FDA.
“McNeil and all drug manufacturers have a corporate responsibility to ensure that their products are high quality, safe, and effective,” Ms. Autor said. “When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary action to solve the problem.”
Based on a recent inspection of McNeil’s primary manufacturing site in Puerto Rico, the FDA issued a warning letter on Jan. 15 citing multiple violations of current good manufacturing practice requirements. The company has 15 working days to respond to the FDA.
In a statement, McNeil Consumer Healthcare said it is continuing its investigation and is ceasing shipment of products produced using materials that were shipped on wood pallets treated with TBA. The company is also requiring suppliers who ship materials to their plants to discontinue the use of these pallets.
