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

Recall Number: D-0980-2017

Firm: Hospira Inc., A Pfizer Company

Classification: Class III

Status: Terminated

Report Date: 20170726

Initiation Date: 20170706

Termination Date: 20190910

Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point

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