Product: Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540
Reason for recall: Failed Impurities/Degradation Specifications; 9 month stability timepoint
Recall initiated: 20151231
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated