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
SAPD searches for robbery suspect (March 26, 2015)
TxDOT closes I-35 north of Georgetown (March 26, 2015)
F.M. 3191 closed in Karnes County (March 25, 2015)
No injuries in Floresville bus crash (March 24, 2015)
Flash flood warning for Karnes, southeastern Wilson counties until 8:45 a.m. (March 21, 2015)
Latest from Wilson County Garden Day (March 20, 2015)
Wilson, Atascosa, Bexar, surrounding counties under flash flood watch (March 20, 2015)
Weekend cancellations due to bad weather (March 19, 2015)
Senate passes open carry gun bill (March 17, 2015)
Wilson County Garden Day is March 21 (March 17, 2015)
Joint statements issued on evolving role in Alamo management (March 12, 2015)
Wilson County residents report 'explosion' noise (March 12, 2015)
U.S. 87 closed north of Nixon (March 10, 2015)
Flash flood watch (March 9, 2015)
Officials charge McQueeney man in Guadalupe County shootings (March 9, 2015)
Rainfall report: March 3-9 (March 9, 2015)
DPS Increases Spring Break DWI Enforcement (March 6, 2015)
Search continues for Guadalupe County gunman (March 6, 2015)
UPDATE: Officials release sketch of suspected Guadalupe County gunman (March 5, 2015)
Bexar County officials seek help in identifying human remains (March 4, 2015)
Dump truck overturns south of La Vernia (March 4, 2015)
Texas AG Responds to Administration Request to Stay Executive Amnesty Ruling (March 4, 2015)
Body found in creek near Stockdale (March 3, 2015)
Public’s Help Needed to Find Child Possibly Exposed to Rabies in Austin (March 3, 2015)