Ortho-McNeil Neurologics recalled about 57,000 bottles of the migraine medicine Topamax after four consumer complaints about a foul odor, the company said today. Topamax is also used to treat seizures in children.
The company said the odor is believed to be caused by trace amounts of a chemical used to preserve the wooden pallets the medicine sits on in storage -- that's the same cause that prompted gigantic recalls of Tylenol and other over-the-counter medications at McNeil Consumer Healthcare. The two companies are both part of Johnson & Johnson.In a letter to pharmacies announcing the recall, Ortho-McNeil said consumers complained about musty, moldy odors; some also reported getting sick with gastrointestinal symptoms. However, the company said there have been no serious illnesses connected with taking the recalled medicine.
Included in the recall are two lots of Topamax tablets 100mg bottles, 60 count, with the NDC Code 50458-641-65. The bottles have the lot numbers 0KG110 or 0LG222, with the expiration dates of 06-2012 and 09-2012, respectively. The lots were shipped between Oct. 19, 2010 and Dec. 28, 2010 through the United States and Puerto Rico.
Ortho-McNeil said it's working with the U.S. Food and Drug Administration and also has taken steps to ensure chemically-treated wood pallets aren't used by its suppliers.
Consumers who notice an odor from their Topamax should return the medicine to the pharmacy and contact their doctor with questions. If there's no foul odor, consumers don't have to do anything for this recall. Call the company at (866) 536-4398 weekdays between 9 a.m. and 5 p.m. Eastern Time.
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