TOPOMAX recall announced for two lots of prescription medication

TOPOMAX recall announced for two lots prescription medication

Best Syndication News

(Best Syndication News) - Two lots of TOPAMAX® (topiramate) 100mg dosage with 60 tablets in the bottle have been voluntarily recalled because of an unusual odor said the manufacturer, Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. The smell they believe is related to a trace amount of TBA (2,4,6 tribromoanisole). The TBA could have come from a chemical preservative that is applied to wood such as the pallets that were used during transportation. The company received four consumers that reported the smell, which prompted the voluntary recall.

The recall involves around 57,000 bottles, but they believe there are less than 6,000 bottles that are in the marketplace. The two lots were shipped to US and Puerto Rico locations between October 19, 2010 and December 28, 2010.


Package Description NDC Code Lot Number Expiry
TOPAMAX® (topiramate) TABLETS 100mg Bottles of 60
Tablets
50458-641-65 0KG110 06/01/12
TOPAMAX® (topiramate) TABLETS 100mg Bottles of 60
Tablets
50458-641-65 0LG222 09/01/12

The trace amounts of the TBA chemical is not considered to be toxic. The worst reports that the company has received is temporary gastrointestinal symptoms. There have been no reports of serious adverse events reported relating to this particular TOPAMAX® recall.

Consumers or healthcare professionals with questions regarding TOPOMAX can call 1-866-536-4398 (Monday – Friday, 9 am – 5pm ET). More information about the recall is available at Topamax.com, RxForSafety.com, and OrthoMcNeilNeurologics.com.

BY: N Wilson

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