Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326

Recall Number: D-0243-2015

Firm: Apotex Inc.

Classification: Class III

Status: Terminated

Report Date: 20141112

Initiation Date: 20141016

Termination Date: 20160930

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326