Medication Monitor

Generic Name (Trade Name—Company)
May 1, 2011


(Topamax—Ortho-McNeil Janssen)
Odor prompts recall of two lots

Two lots of Topamax 100 mg tablets (0KG110 and 0LG222) have been voluntarily recalled by Ortho-McNeil Janssen after a small number of patients reported 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 where products are transported and stored. Although TBA is considered to be nontoxic, it can generate an offensive odor and some patients reported temporary gastrointestinal symptoms.