Akorn, Inc. recalls Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC,
Recalled June 7, 2023 · FDA recall D-0838-2023 · Akorn
Hazard
CGMP Deviations: Firm went out of business and could no longer continue stability studies. · FDA Class II
Units
N/A
Sold at
Nationwide in the USA and Puerto Rico
Description
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →