Class II · Moderate risk Ongoing
Cetrorelix Acetate for Injection
Reason Defective Delivery System: Missing or duplicated needles within the injection kit
Cetrotide
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
What was recalled
Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1
- Recalling firm
- EMD Serono, Inc.
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1379-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Cetrorelix recalls
See all
Class II · Moderate risk Ongoing
Cetrorelix Acetate for Injection
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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