The Food and Drug Administration is expanding a recall of TYLENOL Arthritis Pain Caplets in the 100 count bottle. The bottles have a distinctive red EZ-Open Cap.
In consultation with drug maker, McNeil PPC, all lots of the pain reliever are now being recalled because of a production problem.
Five lots were recalled in November due to an unusual moldy, musty, or mildew-like odor coming from the bottles. That was associated with stomach pain, vomiting, diarrhea, and nausea.
The odor is believed to come from a chemical 2,4,6-tribromoanisole believes to be coming from the chemical that is used to treat the wooden pallets that are used in the transport and storage of packing materials.
So far, consumer reports to McNeil were for non-serious illness.
McNeil Health Care is a subsidiary of Johnson & Johnson, the New Brunswick, N.J. company which posted $16 billion in sales in 2008, reports AP.
Consumers who purchase the TYLENOL Arthritis Pain should stop using the product and contact McNeil Consumer Healthcare for a refund or replacement.
And consumers can report any adverse reactions to the FDA’s MedWatch program, which tracks problems nationwide.
This has not been a good year for the maker of Tylenol.
In September, McNeil recalled 57 lots of children’s liquid Tylenol because of bacterial contamination.
The potential for liver damage was underscored by an FDA panel in July, which called for a lower dose of Tylenol and other acetaminophen products. #