NEW YORK (CNNMoney.com) -- Johnson & Johnson on Thursday announced a recall of 57,000 bottles of the prescription anti-seizure medication Topamax following consumer complaints of an "uncharacteristic odor."
Johnson & Johnson (JNJ, Fortune 500) said the recall represents two lots of the Topamax 100 mg tablets made by its Ortho-McNeil Neurologics division.
The affected drugs were shipped and distributed between Oct. 19, 2010 and Dec. 28, 2010 in the United States and Puerto Rico.
The company said it believes fewer than 6,000 bottles of the medicine remain in the marketplace to be recalled.
However, Ortho-McNeil Neurologics said it does not anticipate a product shortage resulting from the recall.
J&J said it initiated the recall after receiving four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).
Last month, the government announced it was taking over three Tylenol plants operated by McNeil following a wave of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.
McNeil recalled more than 50 million bottles of Tylenol, Motrin and Benadryl products in 2010 after receiving similar complaints of an unusual moldy, musty odor.
The company said at the time that the smell was caused by trace amounts of the same chemical, TBA, which is applied to wooden pallets used to transport and store packaging materials.
While not considered to be toxic, J&J said TBA can generate an offensive odor, and a very small number of patients have reported temporary gastrointestinal symptoms.
As it relates to Topamax, the company said there have been no reported serious adverse effects caused by the presence of TBA.
The company said no consumer actions are required. But patients taking Topamax 100 mg tablets who experience an uncharacteristic odor should return the tablets to their pharmacist, and contact their health care professional if they have questions.
J&J said patients or health care professionals can contact the Topamax helpline at 1-866-536-4398 Monday through Friday, 9 a.m. to 5 p.m. ET.
Additional information about the recall can be found on Topamax.com, RxForSafety.com and OrthoMcNeilNeurologics.com.
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