McNeil announces voluntary, precautionary recall of one lot of Tylenol 8 Hour caplets in the U.S. and Puerto Rico.
McNeil Consumer Healthcare announced this week that one lot of 50-caplet Tylenol 8 Hour (acetaminophen) bottles will be recalled due to “a small number of complaints of a musty or moldy odor.” The company reported that this odor may be caused by trace amounts of 2,4,6-tribromoanisole.
In January, McNeil recalled 53 million bottles of more than two dozen OTC products, including Tylenol, Motrin, and Rolaids, because of musty odors. This smell was later traced to the presence of 2,4,6-tribromoanisole in wooden pallets that held packaging materials.
The risk of adverse medical events resulting from this potential contamination is remote, McNeil reported. Observed events reported for this lot were “temporary and nonserious,” according to the company’s news release, and the recall is a precautionary measure.
The affected lots of Tylenol 8 Hour were sold in the United States and Puerto Rico. The recalled product is lot number BCM155.
Patients who purchased product from this lot should stop using the product and contact McNeil Consumer Healthcare at www.tylenol.com or 888-222-6036 for instructions about receiving a rebate or product coupon. Patients with medical concerns should contact their health care provider, and any adverse reactions should be reported to FDA MedWatch.
