AAFES RECALL NO. 09-111
RELEASE DATE: 21 December, 2009
SUBJECT: QA HAZARDOUS RECALL – CONSUMER HEALTHCARE ANNOUNCES VOLUNTARY RECALL OF ALL LOTS OF TYLENOLŪ ARTHRITIS PAIN 100 CT. WITH EZ-OPEN CAP
SCOPE: WORLDWIDE
In cooperation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare is expanding a voluntary recall issued in November 2009, to include all lots of TYLENOLŪ Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP.
ISSUE: 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.
INCIDENTS/INJURIES: There have been no incidents reported to date.
PRODUCT INFORMATION:
UPC # Product Description 0045-0838-21 TYLENOLŪ ARTHRITIS PAIN CAPLET 100 COUNT BOTTLES (with red EZ-OPEN CAP) NOTE: Only the TYLENOLŪ Arthritis Pain Caplet 100’s with the distinctive red EZ-OPEN CAP are affected by this action. All other TYLENOLŪ Arthritis Pain products remain commercially available. McNeil Consumer Healthcare will reintroduce the TYLENOLŪ Arthritis Pain Caplet 100 count product by January, 2010 after moving production to a new facility.
REMEDY / CONSUMER INFO: Consumers should immediately stop using the affected product and contact the McNeil Consumer Call Care Center for a refund or replacement at: 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) or log on to the internet at: www.tylenol.com. Consumers who have medical concerns or questions should contact their healthcare provider.
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