Medication Monitor

Generic Name (Trade Name—Company)
June 17, 2011


(Risperdal—Ortho-McNeil-Janssen, Patriot Pharmaceuticals)
Second-generation antipsychotic agent recalled

Ortho-McNeil-Janssen is initiating a voluntary recall of one lot of Risperdal (risperidone) 3 mg tablets (Lot #0GG904, Expiration Date May 2012, NDC #50458-330-06) and one lot of risperidone 2 mg tablets (Lot #0LG175, Expiration Date Aug 2012, NDC #50458-593-60 ), marketed by Patriot Pharmaceuticals. Both are packaged in bottles containing 60 tablets. The recalls stem from two consumer reports of an uncharacteristic odor thought to be caused by trace amounts of 2,4,6 tribromoanisole (TBA). Although not considered to be toxic, TBA can generate an offensive odor and a very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odor.