Product: 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
Reason for recall: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated: 20230426
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated