Johnson & Johnson has recalled yet another product -- topiramate (Topamax) -- because of a strange odor thought to be caused by the chemical 2,4,6 tribromoanisole (TBA).
Topiramate is an anticonvuslant used to control seizures in patients with epilepsy. It is also approved for prevention of migraines.
The recall affects two lots -- 0KG110 and 0LG222 -- of 100 mg Topamax tablets in 60-count bottles and involves about 57,000 bottles of the drug.
TBA is the same chemical preservative thought to be responsible for the musty odor that has caused the recall of some 500 lots of other J&J products, including Tylenol.
Risk of adverse events is low, J&J said in an urgent recall notice.
No adverse events related to TBA in the recalled lots have been reported, although complaints related to odor concerns have included reports of gastrointestinal symptoms, the statement said.
The notice included instructions for wholesalers and pharmacists.
Wholesalers should cease distribution and quarantine any affected lots, return the recalled product, and notify customers who may have received the products about the recall, the statement said.
Pharmacists were instructed to return the affected product after it is quarantined from other supplies of the drug.
The two lots were distributed from Oct. 19, 2010 to Dec. 28, 2010 in the U.S. and Puerto Rico, the statement said.