Product: Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.
Reason for recall: Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Recall initiated: 20140320
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated