On April 19, 2023, a Class II recall was initiated for Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL. The product is a single dose sterile prefilled syringe intended for subcutaneous use, distributed by Ferring Pharmaceuticals Inc. of Parsippany, NJ, under NDC 55566-1010-1.
The recall was initiated by Sun Pharmaceutical Industries Ltd. The stated reason for the recall is the presence of particulate matter, specifically a piece of glass found in a prefilled syringe.
The recall is classified as Class II. The FDA recall status for this action is listed as terminated. The event record does not provide additional detail beyond the classification, reason, firm, and dates listed here.
This report reflects only the information contained in the recall record identified as D-0569-2023. No further outcomes, patient impacts, or additional findings are included in the available data. For general background on this compound, readers can consult the compound overview.