Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01

Recall Number: D-1184-2018

Firm: Pfizer Inc.

Classification: Class III

Status: Terminated

Report Date: 20180919

Initiation Date: 20180828

Termination Date: 20200626

Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01