Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.

Recall Number: D-1839-2019

Firm: Akorn, Inc.

Classification: Class III

Status: Terminated

Report Date: 20190904

Initiation Date: 20190806

Termination Date: 20220728

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.

Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.