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Two Lots of Topomax Recalled Due to Suspected Presence of TBA
Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, has initiated a voluntarily recall of two lots of Topomax® (topiramate) 100 mg tablets due to four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of 2,4,6 tribromoanisole (TBA). TBA is not considered to be toxic, but can cause an offensive odor and a small number of patients have reported temporary gastrointestinal symptoms. The two affected lots (0KG110 and 0LG222) were shipped between October 19, 2010 and December 28, 2010, and were distributed in the US and Puerto Rico. The company believes there are fewer than 6,000 bottles remaining in the marketplace, although the recall affects approximately 57,000 bottles. Ortho-McNeil Neurologics has initiated this recall at the wholesale and retail (pharmacy) level. Patients taking Topomax 100 mg tablets who notice an uncharacteristic odor associated with their medication should return the tablets to their pharmacist, and contact their health care provider if they have questions. Patients or health care providers can contact the Topomax phone line with questions at 866/536-4398. More information about this recall is available in a press release on the FDA Web site.
