Akorn, Inc.: Drug Recall
Recall #D-0791-2023 · 04/26/2023
Class II: Risk
Recall Details
- Recall Number
- D-0791-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Akorn, Inc.
- Status
- Ongoing
- Date Initiated
- 04/26/2023
- Location
- Gurnee, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Reason for Recall
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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
Distribution Pattern
Nationwide in the USA and Puerto Rico
Other Recalls by Akorn, Inc.
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.