Cetrorelix Acetate for Injection recalled over manufacturing violations

Recall date

April 26, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Akorn, Inc. recalls Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophili…

Recall number

D-0791-2023

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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