Akorn, Inc. recalls Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophiliz
Recalled June 7, 2023 · FDA recall D-0791-2023 · 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
Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only, Manufactured by: GP Pharm S.A. Barcelona, Spain (ESP) -08777, 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 →