McNeil-PPC Inc., a Johnson & Johnson company, is recalling 34,000 bottles of Tylenol 8 Hour Extended Release Caplets due to a musty or moldy odor, which has been the subject of five other recalls of the over-the-counter medication.
The odor is thought to be caused by the presence of trace amounts of chemicals called 2,4,6-tribromoanisole or TBA and 2,4,6-trichloroanisole or TCA, the company said in a statement. The chemicals are used to treat wooden pallets on which bottles of the medication are stored and shipped.
The company said the action is voluntary precaution, and the risk of adverse medical reactions is remote.
The product was manufactured at the McNeil Consumer Healthcare plant in Fort Washington, Pa., before the closure of the facility in April 2010.
The lot number for the recalled product can be found on the side of the bottle label: ADM074. The UPC code is 300450297181.
Consumers who purchased medication from the lot involved in the recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 888-222-6036 Monday through Friday from 8 a.m. to 8 p.m. ET, for instructions about receiving a refund or product coupon.
Consumers who have medical concerns or questions should contact their healthcare provider.
Any adverse reactions can also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by mail, or by fax:
- Online: www.fda.gov/medwatch/report.htm.
- Mail: Use the postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 800-FDA-0178.
For information on other recalls, see www.recalls.gov.
