Product: 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
Reason for recall: Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Recall initiated: 20141016
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated