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

Recall Number: D-0659-2016

Firm: Sandoz Inc

Classification: Class III

Status: Terminated

Report Date: 20160217

Initiation Date: 20151231

Termination Date: 20170412

Failed Impurities/Degradation Specifications; 9 month stability timepoint

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