Johnson & Johnson recalled 57,000 bottles of the prescription anti-seizure medication Topamax following consumer complaints of an “uncharacteristic odor.”
The recall represents two lots of the Topamax 100 mg tablets made by its Ortho-McNeil Neurologics division, J&J said.
The affected drugs went out between Oct. 19, 2010 and Dec. 28, 2010 in the United States and Puerto Rico.
The company said fewer than 6,000 bottles of the medicine remain in the marketplace.
J&J said it initiated the recall after receiving four consumer reports of an uncharacteristic odor caused by trace amounts of TBA (2,4,6 tribromoanisole).
J&J remains haunted by recalls as last month, the government said it was taking over three Tylenol plants operated by McNeil following a wave of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.
McNeil recalled more than 50 million bottles of Tylenol, Motrin and Benadryl products in 2010 after receiving similar complaints of an unusual moldy, musty odor.
The company said at the time the smell was from trace amounts of the same chemical, TBA, which goes on wooden pallets used to transport and store packaging materials.
While not considered toxic, J&J said TBA can generate an offensive odor, and a very small number of patients have reported temporary gastrointestinal symptoms.
As it relates to Topamax, the company said there have been no reported serious adverse effects caused by the presence of TBA.