McNeil Consumer Healthcare Recalls TYLENOL(R) Arthritis Pain Caplets

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In consultation with the Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is expanding its voluntary recall of Tylenol Arthritis Pain Caplet 100 count bottles to include all available product lots.

In November 2009, 5 lots of the medication were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting, and diarrhea. The company now is expanding the recall as a precaution to include all 100-count bottles with the distinctive red EZ-Open Cap. No other Tylenol Arthritis Pain products are affected by the recall.

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The odor is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole, which is likely from the wooden pallets used to store and transport packaging materials for the medication. The health effects of the compound have not been well studied, and the company reports that all incidents to date have been temporary and non-serious.

Consumers who purchased Tylenol Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap that bear the UPC code 0045-0838-21 and NDC code 8382100 should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. The customer service line is 1-888-222-6036 and is available Monday through Friday 8 am to 8pm Eastern Time, and 9am to 5pm on Saturday and Sunday.

Anyone who has adverse effects from using Tylenol Arthritis Pain medication should contact their health provide and report the incident to FDA’s Medwatch Program by fax at 1-800-FDA-0178 or mail at FDA, 5600 Fishers Lane, Rockville MD 20852-9787.

For the full list of recalled product lot numbers, the company website is www.tylenol.com. For more information on the FDA’s Medwatch Program, the website is www.fda.gov/medwatch.

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