The FDA is criticizing Johnson & Johnson’s McNeil for knowing about a musty odor in Tylenol and other products for over a year without taking drastic action.
According to the FDA, the company discovered the problem in November 2008, but didn’t get serious about it until now, when more than 70 people have become sick from its OTC drugs with symptoms including nausea, stomach pain, vomiting and diarrhea.
The agency has now sent McNeil a warning letter for violating manufacturing standards and being slow to report the problem to the public.
Last year, in response to the musty odor, McNeil recalled 6 million packages of Tylenol. Now, it’s expanding the recall to 80 million packages of Tylenol and Motrin, Benadryl, St. Joseph Aspirin, Rolaids, and Simply Sleep. For the complete list of recalled products, click here.
The smell is caused by trace amounts of a chemical called 2,4,6-tribromoanisole, which is broken down by fungi from a fungicide [and] is used to treat wooden pallets that transport and store packaging materials, news media reports.
It is unlikely the smell is caused by the deposition compound from the fungicide, a health observer commented. It could come from 2,4,6-tribromophenol, which is also used as a flame retardant in paper, plastic and other materials. –FoodConsumer
If you are worried about any of the OTC drugs in your home, visit http://www.mcneilproductrecall.com for guidelines on identifying packages that are part of the recall. If you find your package on the list, please discard it or return it.
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