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Recalls of TOPAMAX

Recalls of TOPAMAX

Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX®

See the recall notice here:  http://www.fda.gov/Safety/Recalls/ucm251515.htm

Additional information about the recall can be found on Topamax.com, RxForSafety.com, and OrthoMcNeilNeurologics.com.

_______________________

This is an excerpt from the Topamax.com website:

Reason for Recall:
An investigation into consumer complaints for musty moldy odors revealed some bottles may contain trace amounts of 2,4,6 tribromoanisole (TBA).

Potential Health Hazard:
There is a low likelihood of patients experiencing serious adverse events resulting from exposure to TBA in these lots of TOPAMAX®. No serious adverse events in relation to TBA exposure have been reported in relation to the impacted lots. Of the complaints received for odor, some patients also reported gastrointestinal symptoms. To facilitate continuity of care it is important to note that patients should continue to take the product as prescribed if there is no unusual odor present.

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