Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Impurities/Degradation Specifications
Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.
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 Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Reason Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.