BETHESDA, MD 14 April 2011—Ortho-McNeil Neurologics this morning announced a recall of lots 0KG110 and 0LG222 of Topamax 100-mg tablets because consumers have complained that the product has an uncharacteristic odor.
The company, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., said the odor may be caused by trace amounts of 2,4,6-tribromoanisole (TBA), a byproduct of a chemical preservative sometimes applied to the wood of pallets.
Similar recalls of products from other Johnson & Johnson companies have been occurring for more than a year.
Bottles from the two Topamax lots were shipped between October 19 and December 28, 2010, Ortho-McNeil said.
A "very small number of patients," the company said, have reported temporary gastrointestinal symptoms—none of them serious—from exposure to TBA`s offensive odor.
Patient who detect an uncharacteristic odor in their Topamax 100-mg tablets are being encouraged by the company to return the tablets to their pharmacist. The company said patients who do not detect an uncharacteristic odor should continue to use their supply of Topamax.
Pharmacies are being instructed to contact Stericycle Inc. to arrange for return of product from the two lots.
Ortho-McNeil said it does not expect the recall to result in shortage of the company`s brand-name topiramate product.
