Recall -- Firm Press Release
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McNeil Consumer Healthcare Announces Voluntary Recall of One Product Lot of TYLENOL® 8 Hour Caplets 50 Count Sold in The United States and Puerto Rico
FOR IMMEDIATE RELEASE - October 18, 2010- Fort Washington, PA – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling one product lot of TYLENOL® 8 Hour caplets 50 count bottles to the retail level. McNeil is taking this action 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. 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 for this lot were temporary and non-serious.
The product lot number for the recalled product can be found on the side of the bottle label.
FULL RECALLED PRODUCT LIST:
Tylenol® 8 Hour Caplet 50 count
3 0045-0297-51 8
Consumers who purchased product from the lot included in this recall should stop using the 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.
Any adverse reactions may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).