FDA Safety Alert: RISPERDAL (RISPERIDONE) AND RISPERIDONE: RECALL – UNCHARACTERISTIC ODOR

The Food and Drug Administration (FDA) issued a safety alert regarding Risperdal and Risperidone. Janssen Pharmaceuticals issued a recall of Risperdal (risperidone) lot 0GG904 3mg tablets and risperidone lot OIGI752mg tablets. The recall stems from an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole), a non-toxic byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets used for transporting and storing materials. A small number of consumers have reported temporary gastrointestinal symptoms. Safety Alert: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259901.htm

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