Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX®

Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., today announced it is voluntarily recalling 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.  While the recall encompasses approximately 57,000 bottles of TOPAMAX®, the company believes there are fewer than 6,000 bottles remaining in the marketplace.  The recall stems from four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

Package Description	NDC Code	Lot Number	Expiry
TOPAMAX® (topiramate) TABLETS 100mg  Bottles of 60 Tablets	50458-641-65	0KG110	06-2012
		0LG222	09-2012

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.  In January 2010, we instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to verify that they do not use pallets made from chemically-treated wood.  An internal investigation is underway with our suppliers to evaluate the potential source of this TBA issue.   In addition, we are working with peer companies to better understand how and where TBA is entering and impacting our supply chains and what we can do to further mitigate this exposure.

Source is the J and J site:   Here.