Manufacturer Recalls Two Lots of Risperdal (risperidone) and Risperidone Due to Possible TBA

June 30, 2011 9:32 AM Topics: Patient safety

A recall of two lots of Risperdal^® (risperidone) 3 mg tablets and risperidone 2 mg tablets has been initiated by the manufacturer due to possible trace amounts of TBA (2,4,6 tribromoanisole). Ortho-McNeil-Janssen Pharmaceuticals notes that the recall was initiated due to consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA. These medications are used for the treatment of schizophrenia and bipolar mania in adults and adolescents, and for treatment of irritability associated with autistic disorder in children and adolescents ages five to 16 years. Patients being treated with these drugs should not stop taking their medication. Instead, anyone experiencing an uncharacteristic odor associated with Risperdal 3 mg tablets or risperidone 2 mg tablets should return the tablets to their pharmacist, and contact their health care provider if they have questions.
The following lots and quantities are affected by the recall:

• Risperdal, lot 0GG904 (16,000 bottles; shipped between 8/27/2010 and 2/15/2011)
  Approximately 1,600 bottles of Risperdal from this lot remain in the marketplace.
• Risperidone, lot OIG175 (24,000 bottles; shipped between 11/10/2010 and 1/01/2011)
  Fewer than 1,200 bottles of risperidone from this lot remain in the marketplace.

More information is available in a safety alert on the FDA Web site.