Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37

Recall Number: D-0698-2018

Firm: InvaGen Pharmaceuticals, Inc.

Classification: Class III

Status: Terminated

Report Date: 20180418

Initiation Date: 20180305

Termination Date: 20210120

Failed impurities/degradation specifications: Failure to water content and impurity

Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37