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Johnson & Johnson has announced another recall, this time on the prescription anti-epilepsy drug Topamax (tropiramate). Consumers have reported an uncharacteristic musty odor in the pills. The odor is thought to be caused by trace amounts of TBA (2, 4, 6 tribromoanisole), and is not considered to be toxic, though some consumers have reported temporary gastrointestinal symptoms.
Topamax is used alone or with other medications to treat partial onset or primary generalized tonic-clonic seizures in adults and children. It is also prescribed as a prophylaxis of migraine headaches. The odor-causing TBA is a fungal compound found in packing material.
The recall includes two lots (0KG110 and 0LG222)of 100mg tablets (60 tablets per bottle). The pills were produced by the Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson.
The Topamax recall is the latest in a string of recalls of Johnson & Johnson products that include a long list of popular over-the-counter medicines such as Tylenol and Benadryl. At least one recall of OTC medicines was due to pills with foul odors. That odor was also caused by the presence of TBA and linked to wooden palates used to ship the drugs.
The previous Johnson & Johnson medicine recalls were produced in the company’s McNeil Consumer Healthcare plant in Fort Washington, Pa. The recalled Topamax was produced at the company’s plant in Gorabo, Puerto Rico.
Patients taking Topamax 100mg who notice an odor associated with their medication should return the tablets to their pharmacist and contact their doctors if they have questions or experience any health problems. Any side effects should be reported to the Food and Drug Administration MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.
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