FDA Drug recall D-0791-2023
Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for recon…
- FDA Drug
- Class II
- ongoing
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for recon… by Akorn, citing CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0791-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-26 |
| Published | 2023-06-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
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
Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0791-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.