Ortho-McNeil issues Topamax recall
Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced April 14 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).
The recalled products have the following description:
Topamax (topiramate) tablets 100mg, bottles of 60 tablets, NDC Code 50458-641-65
Lot number: OK110. Expiry 06/2012
Lot number: Lot OLG222. Expiry date 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.
The voluntary recall, being implemented in cooperation with the U.S. Food and Drug Administration (FDA), was initiated after enhanced surveillance and complaint monitoring programs escalated odor-related reports. While not considered to be toxic, TBA can generate an offensive odor and a very small number of patients have reported temporary gastrointestinal symptoms. As it relates to TOPAMAX®, there have been no reported serious adverse events caused by the presence of TBA.
Ortho-McNeil Neurologics has initiated this recall at the wholesale and retail (pharmacy) level and is communicating this information to these customers. The Company does not anticipate a product shortage resulting from this action.
TOPAMAX® 100mg Tablets are yellow debossed with “OMN” on one side and “100” on the other. 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.
Your Opinions and Comments
Be the first to comment on this story!
You must be logged in to post a comment.
Breaking News Archives
Severe thunderstorm watch until 4 a.m. (May 28, 2015)
WCN special edition (May 28, 2015)
Governor Abbott Adds 24 Counties To Disaster Declaration, including Wilson (May 25, 2015)
National Weather Service continues alerts (May 25, 2015)
Rain leads to flooding, road closures (May 25, 2015)
Update: Tornado warning extended: National Weather Service (May 25, 2015)
Flash flood warning until 12:15 a.m. (May 23, 2015)
Tornado watch until 3 a.m. (May 23, 2015)
Flash flood watch for all of South Central Texas, May 23-24 (May 22, 2015)
Update: Encana workers secure blown Karnes County gas well (May 21, 2015)
Rainfall report: May 11-17 (May 18, 2015)
Flash flood warning issued May 15, expires at 1:45 p.m. (May 15, 2015)
Union Pacific suspects weather caused Pleasanton derailment (May 15, 2015)
Events rescheduled this weekend (May 14, 2015)
Severe thunderstorms, flooding possible in area (May 14, 2015)
Tornado watch for South Central Texas (May 13, 2015)
Weather Updates; Road closures; Flash flood warning until 5:15 p.m. (May 13, 2015)
Flash flood watch continues May 12 (May 12, 2015)
Officers nab fleeing fugitive (May 12, 2015)
Rainfall reports for May 4-10 (May 11, 2015)
Update: Six suffer injuries in U.S. 87 crash (May 7, 2015)
Cornyn Presses State Department On Clinton Emails (May 6, 2015)
ADL condemns violence at Garland event (May 4, 2015)