The odor is thought to be caused by a chemical -- 2,4,6-tribromoanisole or TBA -- leached into product packaging by wooden storage palettes. TBA is a pesticide and flame retardant.
"The risk of adverse medical events is remote," states a news release by J&J's McNeil Consumer Healthcare division.
The recalled product is Tylenol 8 Hour Caplet 50 Count. The recalled product carries these codes:
- Lot number BCM155
- NDC Code 50580-297-50
- UPC # 3 0045-0297-51 8
People who bought this product should stop using it and contact McNeil Consumer Healthcare for a refund or product coupon. Adverse events related to the product should be reported to the FDA's Medwatch Adverse Event Reporting Program at 800-FDA-0178.
Last January, the FDA issued a warning letter to McNeil, complaining that the firm violated Good Manufacturing Practices by failing to fully investigate consumer complaints of a musty odor in its products. The FDA said the company began receiving complaints in 2008.
Previous recalls of McNeil products because of the musty odor were issued in November and December 2009, and in January, June, and July 2010.