FDA Drug recall D-0569-2023
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, S…
- FDA Drug
- Class II
- terminated
- Published 2023-05-03
On 2023-05-03 the FDA classified a Class II recall of Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, S… by Sun Pharmaceutical Industries, citing presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0569-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-04-19 |
| Published | 2023-05-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
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
Reason
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Identifiers
| ndc | 55566-1010-1 |
|---|---|
| code_info | Lot #: HAD1190A, Exp. 02/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0569-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.