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TITUSVILLE, N.J. — Ortho-McNeil-Janssen Pharmaceuticals Inc. is voluntarily recalling two lots of Topamax 100mg tablets.
The company said Thursday that the Topamax recall, by its Ortho-McNeil Neurologics division, stems from four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).
According to the drug maker, the two lots of Topamax (topiramate) were shipped between Oct. 19 and Dec. 28, 2010, and were distributed in the United States and Puerto Rico. Although the recall encompasses about 57,000 bottles of Topamax, the company said it thinks there are fewer than 6,000 bottles remaining in the marketplace.
Ortho-McNeil Neurologics has initiated the recall at the wholesale and retail levels. The company said it doesn’t expect a product shortage resulting from the recall.
Ortho-McNeil said the voluntary recall, being implemented in cooperation with the Food and Drug Administration, was initiated after enhanced surveillance and complaint monitoring programs escalated odor-related reports. Though not considered toxic, TBA can generate an offensive odor, and a small number of patients have reported temporary gastrointestinal symptoms, according to the company. TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which products are transported and stored.
Topamax is indicated for the treatment of seizures in adults and children who are at least 10 years old, and the medication is used with other medications to treat seizures in adults and children who are at least 2 years old. Topamax is also used to prevent migraine headaches in adults.
