Topiramate (Topamax) - Recall
April 15, 2011
Ortho-McNeil is voluntarily recalling 2 lots of topiramate (Topamax) 100 mg tablets (NDC 50458-641-65). This action is being taken in response to 4 reports from consumers of an uncharacteristic “musty” odor. Approximately 57,000 bottles from the affected lots were distributed in the US and Puerto Rico from 10/19/2010 to 12/28/2010. However, the company estimates that less than 6,000 bottles of the following affected lots remain in circulation:
- Lot # 0KG110, expires 6/2012
- Lot # 0LG222, expires 9/2012
The odor is believed to be caused by trace amounts of 2,4,6-tribromoanisole (TBA), a byproduct of preservatives sometimes used for building wooden shipping and storage pallets. Although TBA is usually considered nontoxic, it can cause an offensive odor, and a few patients have reported transient gastrointestinal symptoms after its ingestion. No serious adverse effects have been associated with TBA exposure from Topamax 100 mg tablets. Ortho-McNeil now requires that suppliers avoid using pallets made from chemically-treated wood.
Patients should return Topamax 100 mg tablets to the pharmacy if they notice any strange odors, and contact their primary caregiver with any questions. Patients and healthcare providers may also contact Ortho-McNeil’s Topamax information line at 1-866-536-4398, weekdays from 9:00 AM to 5:00 PM Eastern Standard Time. Report any adverse events to the FDA MedWatch program. Additional information is available at the following link:
- MedWatch alert:
- Press Release:
April 15, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.