Massive OTC recall affects two dozen J&J products
Storage on wooden pallets cited as reason for musty, moldy,
mildew odors.
Specific lots of more than two dozen nonprescription product lines
are being recalled because of consumer complaints about an unusual
moldy, musty, or mildew-like odor leading in some patients to transient
gastrointestinal symptoms. FDA and McNeil Consumer Healthcare said on
Friday that consumers should stop using the recalled products and
contact the company for refunds.
This latest action expands a similar recall in December 2009 of all
lots of Tylenol Arthritis Pain 100 count with EZ-Open Caps. The company
says that the problematic smell resulted from presence of
2,4,6-tribromoanisole, a breakdown product of a chemical used to treat
the wooden pallets on which the products were stored. Nausea, stomach
pain, vomiting, and diarrhea have been reported by a small number of
patients after using the products.
The recall includes Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep,
and St. Joseph products distributed in the United States, United Arab
Emirates, and Fuji. A PDF file with all affected products and lots can
be downloaded at http://www.fda.gov/downloads/Safety/Recalls/UCM197813.pdf.
Information is also available on the McNeil Consumer Healthcare
website and by telephone at 888-222-6036.
Adverse reactions can be reported to the FDA’s MedWatch Program
by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane,
Rockville, MD 20852-9787, or on the MedWatch website.
Web links
L. Michael Posey, BPharm (mposey)
Posted January 16, 2010, 7:00 pm EST
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