Akorn recalls Cetrorelix Acetate injections due to manufacturer closure preventing stability testing. All units are affected. No remedy specified in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all Cetrorelix Acetate injections because the manufacturer closed and can no longer test product stability. This means the medication might not be safe for use after the recall date.
The manufacturer closed and stopped stability testing, which means the drug's safety and effectiveness could be compromised over time. Without ongoing testing, the medication might degrade or become unsafe for use.
All owners of Cetrorelix Acetate injections are affected. Patients receiving this medication for fertility treatments are most at risk.
Check for the product name 'Cetrorelix Acetate for Injection, 0.25 mg' on the label. All units are affected regardless of lot number or purchase date.
Look for the product name 'Cetrorelix Acetate for Injection, 0.25 mg' on the label.
The official notice does not specify any remedy.
The manufacturer closed and can no longer perform stability testing, which could affect the product's safety.
The official notice does not specify a stop-use instruction.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0791-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0791-2023 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
