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Tylenol 8 Hour Caplets 50 Count: Recall

Tue, 10/19/2010 - 12:35pm
U.S. Food & Drug Administration

AUDIENCE: Consumer, Pharmacy

ISSUE: McNeil is recalling TYLENOL 8 Hour caplets 50 count bottles to the retail level following a small number of complaints of a musty or moldy odor. The uncharacteristic odor is thought to be caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole.

BACKGROUND: This voluntary action is being taken as a precaution and the risk of adverse medical events is remote. To date, observed events reported to McNeil were temporary and non-serious. The product lot number for the recalled product can be found on the side of the bottle label.

RECOMMENDATION: Consumers should stop using the affected product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 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) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.

[10/19/2010 - Press Release - McNeil Consumer Healthcare]

 

    

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