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Recall: 57,000 bottles of Topamax have a musty odor

Consumer Reports News: April 15, 2011 03:38 PM

The U.S. Food and Drug Administration has issued a recall alert for Topamax, an anti-seizure drug made by Ortho-McNeil-Janssen Pharmaceuticals, because of numerous consumer complaints of a musty odor from the drug's bottles.

The affected bottles contain 60 tablets of Topamax, or topiramate, in 100 mg doses and were shipped for distribution in the U.S. and Puerto Rico between last October and December in two lots. The bottles being recalled have labels that bear "NDC code 50450-641-65" and a "Lot Number" of "0KG110" with an expiration date of "06-2012" or Lot Number 0LG222 with a "09-2012" expiration.

As with other, recent recalls of McNeil drugs, the stench from the Topamax bottles is believed to be caused by trace amounts of 2,4,6 tribromoanisole, or TBAs.

The FDA believes TBA contamination isn't harmful to humans. However, some consumers may experience gastrointestinal events from TBA-tainted drugs. The agency advises that users should consult with their physician or pharmacist with any questions.

For more information, you can contact the toll-free Topamax line (866-536-4398, M-F, 9-5 EST) or visit the following websites: Topamax.com, RxForSafety.com, and OrthoMcNeilNeurologics.com.

Sources

Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX [US FDA]

Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX [Johnson & Johnson]

Odd odor prompts drug recall -- again [LA Times]

Paul Eng


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