Johnson & Johnson this Thursday has announced a recall of 57,000 bottles of the prescription anti-seizure medication Topamax following consumer complaints of an “uncharacteristic odor.”
Johnson & Johnson added in a statement that the recall represents two lots of the Topamax 100 mg tablets made by its Ortho-McNeil Neurologics division. These pills were shipped and distributed between Oct. 19, 2010 and Dec. 28, 2010 in the United States and Puerto Rico they revealed. The lot numbers are OKG110 and OLG222. The company said it believes fewer than 6,000 bottles of the medicine remain in the marketplace to be recalled.
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). Ortho-McNeil Neurologics said it does not anticipate a product shortage resulting from the recall.
McNeil has been in trouble before. 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 New Brunswick, N.J., company has now issued 22 product recalls, involving well over 300 million bottles of medicines, since September 2009.
The company defended itself by saying that 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.
The company said that no consumer actions are required. But patients taking Topamax 100 mg who experience an uncharacteristic odor should return the tablets to their pharmacist, and contact their health care professional if they have questions. J&J announced that 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.
Lost revenue stemming from recalls and the lengthy closure of a plant in suburban Philadelphia reduced J&J's 2010 sales by $900 million. In the fourth quarter, J&J posted a 12 percent profit decline and a 5.5 percent drop in sales. The latest bad news for J&J comes just five days before it is scheduled to release first-quarter results. In January, J&J forecast 2011 earnings per share of about $4.85, well below analysts' expectation of $4.99 a share for 2011.
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