Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Defective Delivery System: Missing or duplicated needles within the injection kit
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.
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 CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
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