Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Recall Number: D-0838-2023
Firm: Akorn, Inc.
Classification: Class II
Status: Ongoing
Report Date: 20230607
Initiation Date: 20230426
Termination Date:
Reason for Recall
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product Description
Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs