Product: Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India,  Manufactured for:  Hospira, Inc, Lake Forest, IL 60045 ---  NDC  0409-1140-01
Reason for recall: Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Recall initiated: 20170706
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated