Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains...
FDA Recall #D-0791-2023 — Class II — April 26, 2023
Product Description
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
Reason for Recall
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recalling Firm
Akorn, Inc. — Gurnee, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide in the USA and Puerto Rico
Code Information
All Lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated