J&J Unit Recalls Topamax Lots Over Smell

The Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. (itself a division of Johnson & Johnson) is voluntarily recalling two lots of Topamax (topiramate) 100mg Tablets, shipped between 10/19/2010 and 12/28/2010, and distributed in the U.S. and PR. The recall includes approximately 57,000 bottles of Topamax, but the company believes there are fewer than 6,000 bottles remaining in the marketplace. The recall follows four consumer reports of an uncharacteristic odor, thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole), a byproduct of a chemical preservative sometimes applied to wood used for storage pallets.

In January 2010, in an effort to reduce the potential of TBA contamination, the company required suppliers to verify that they do not use pallets made from chemically treated wood. An internal investigation is underway with suppliers to evaluate the potential source of this TBA issue and where TBA is entering and impacting the supply chain.

While not considered to be toxic, TBA can generate an offensive odor and a small number of patients have reported temporary gastrointestinal symptoms. No reported adverse events caused by the presence of TBA were related to Topamax. The company doesn’t anticipate a product shortage as a result of the recall.