Ortho-McNeil-Janssen announced a voluntary recall of one lot of Risperdal (risperidone) 3mg tablets and one lot of generic risperidone 2mg tablets (Patriot Pharmaceuticals). This recall was initiated following consumer reports of an uncharacteristic odor thought to be caused by trace amounts of 2,4,6 tribromoanisole (TBA). TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which materials are transported and stored. While 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.
The following lots are being recalled:
- Risperdal 3mg tablets, 60 count bottles; NDC# 50458-330-06; Lot# 0GG904; Exp. 5/2012
- Risperidone 2mg tablets, 60 count bottles; NDC# 50458-593-60; Lot#OIG175; Exp. 8/2012
Risperdal is indicated for the treatment of schizophrenia in patients 13–17 years; as monotherapy or in combination with other medicines (valproate or lithium) in adults for the short-term treatment of bipolar mania; or alone in adults, children and adolescents ages 10–17 years for the short-term treatment of bipolar mania; and for the treatment of irritability associated with autistic disorder in children and adolescents ages 5–16 years. Patients who have the recalled products in their possession should not stop taking their medication, but should return the tablets to their pharmacist and contact their healthcare provider with any questions.