In consultation with the US Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc, is expanding its voluntary recall to include all available product lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP. In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odour that was associated with nausea, stomach pain, vomiting and diarrhoea. The recall is being expanded, as a precaution, to include all Tylenol Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP.

The uncharacteristic smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. 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.

Consumers who purchased Tylenol Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement.

Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA’s MedWatch Programme by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Only the Tylenol Arthritis Pain Caplet 100’s with the distinctive red EZ-OPEN CAP are affected by this action. All other Tylenol Arthritis Pain products remain commercially available. McNeil Consumer Healthcare will reintroduce the Tylenol Arthritis Pain Caplet 100 count product by January, 2010 after moving production to a new facility.

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc markets a broad range of well-known and trusted over-the-counter (OTC) products around the globe. McNeil Consumer Healthcare is most widely recognized for the complete line of Tylenol acetaminophen products, the leading pain reliever brand in the adult and paediatric categories.