McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling at the retail level one product lot (60,912 bottles) of TYLENOL, Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recalled product was manufactured in February, 2009. McNeil is taking this action following reports of a musty, moldy odor. This order has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA), which is used to treat wooden shipping and storage pallets in other countries, and was also cited for past recalls.
J&J, the world’s second-largest maker of health-care products, has pulled millions of packages of over-the-counter drugs since last year because of TBA. The company also pulled 40,000 bottles of Risperdal, a schizophrenia drug, on June 17 because of the chemical’s musty odor, which also led the company to recall shipments of the HIV drug Prezista and the seizure medicine Topamax this year.
The 60,912 bottles of Tylenol recalled on June 28th make up one lot of the product and were manufactured in February 2009, J&J said in a statement.
This voluntary action is being taken as a precaution and the risk of serious adverse medical events is remote, according to the company. TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms.