Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1
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 Failed Impurities/Degradation Specifications
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