A recall of Fyremadel (ganirelix acetate) injection was initiated on April 19, 2023. The recall, identified as D-0569-2023, has been classified as Class II by the FDA.
The reason listed for the recall is presence of particulate matter, specifically a piece of glass found in a prefilled syringe. The affected product is Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, supplied as a single dose sterile prefilled syringe for subcutaneous use, NDC 55566-1010-1. The product is distributed by Ferring Pharmaceuticals Inc. of Parsippany, NJ.
The recalling firm associated with this action is Sun Pharmaceutical Industries Ltd. The recall status is listed as terminated.
This classification and the stated reason are reported as facts from the recall record. They do not by themselves indicate that any patient was harmed or that the compound itself is unsafe. Readers can review the compound overview for additional context on ganirelix and its approved use.