Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
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
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.
Reason Defective Delivery System: Missing or duplicated needles within the injection kit
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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