Johnson & Johnson recalls Tylenol

Sunday Jan 17, 2010 (foodconsumer.org) -- Johnson & Johnson's McNeil Consumer Healthcare is expanding its voluntary recall to include all lots of Tylenol's 100 count bottles of arthritis pain caplets because of consumer reports of an unusual moldy, musty odor.

The company voluntarily issued a recall for five lots of this same Tylenol product last year and the recall has been expanded as a precaution, according to McNeal’s press release posted on the Food and Drug Administration website.
 
The smell is caused by trace amounts of a chemical called 2,4,6-tribromoanisole, which is broken down by fungi from a fungicide. 2,4,6-tribromophenol is used to treat wooden pallets that transport and store packaging materials, news media reports.
 
The nasty smell has sickened at least 70 people and triggered a number of symptoms including nausea, stomach pain, vomiting and diarrhea, according to Webmd.com. Johnson &Johnson said the effects were temporary and no serious injury resulted from the exposure.
 
The FDA criticized the company saying that Johnson &Johnson's McNeal had known about the problem with their Tylenol products for over one year, but did not do enough to correct it in November, 2008.
 
The products subject to the recall include all types of products indicated for both children and adults including Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Rolaids, and Simply Sleep.
 
Six million packages of Tylenol were recalled last year and the expanded recall would affect a total of weighty million packages, webmd.com reported.
 
Deborah Autor, the director of the FDA's Office of Compliance of the Center for Drug Evaluation and Research was cited by ABC News as saying the FDA has sent McNeal a warning letter for violating manufacturing standards and failing to report the incident to the agency in a timely fashion.
 
Consumers who have concerns or questions may read more information on the recalled Tylenol products at http://www.mcneilproductrecall.com to identify the recalled batches.
 
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.

Full recalled product list

Reporting by Jimmy Downs and editing by Rachel Stockton