Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has recalled two lots of TOPAMAX® (topiramate) 100mg Tablets. These two lots were shipped between 10/19/2010 and 12/28/2010 and distributed in the U.S. and Puerto Rico. The recall encompasses approximately 57,000 bottles of TOPAMAX®; but, the company believes there are fewer than 6,000 bottles remaining in the marketplace.
The recall is the result of four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole). TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which products are transported and stored.
While no consumer actions are required, patients taking TOPAMAX® 100mg Tablets who experience an uncharacteristic odor associated with their medication should return the tablets to their pharmacist, and contact their healthcare professional if they have questions. Patients or healthcare professionals can contact the TOPAMAX® Line at 1-866-536-4398 (Monday – Friday, 9 am – 5pm ET). Additional information about the recall can be found on Topamax.com, RxForSafety.com, and OrthoMcNeilNeurologics.com.
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