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.

Recall Number: D-1299-2014

Firm: Apotex Inc.

Classification: Class III

Status: Terminated

Report Date: 20140507

Initiation Date: 20140320

Termination Date: 20141223

Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.

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.