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Expanded Tylenol Arthritis Pain Caplet Recall

On January 15, 2010, McNeil PPC, the manufacturer of Tylenol® and the FDA expanded their recall of 100-count bottles of Tylenol Arthritis Pain Caplets with the distinctive red EZ-Open cap. Five lots of Tylenol Arthritis Pain Caplets were recalled due to consumer reports of an unusual moldy or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea.

The odor is caused by the presence of a chemical 2,4,6-tribromoanisole, believed to be the breakdown of a chemical used to treat wooden pallets used for shipping. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious.

Advise your patients who purchased this product from the lots included in this recall to stop using the medicine and contact McNeil Consumer Healthcare for instructions on a refund or replacement. The affected product lot numbers for the recalled products can be found on the side of the bottle label. McNeil can be reached on its Web site or by telephone at 1-888-222-6036 Monday through Friday from 8 am to 8 pm and from 9 am to 5 pm on Saturdays and Sundays.

Any adverse reactions may also be reported to the FDA’s MedWatch Program:

• By fax at 1-800-FDA-0178 (1-800-332-0178)
• By mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
• Or by going to the MedWatch Web site

You may read the complete MedWatch 2010 Safety Alert that includes a link to the McNeil PPC press release. Or you may also read the FDA MedWatch Safety Summary for more in-depth information.