Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Recall Number: D-0802-2023

Firm: Akorn, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20230607

Initiation Date: 20230426

Termination Date:

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs