FDA Drug recall D-0320-2021
Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ…
- FDA Drug
- Class II
- terminated
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ… by Sun Pharmaceutical Industries, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0320-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-15 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | NJ |
Product
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.
Reason
Failed Impurities/Degradation Specifications
Identifiers
| code_info | Lots JKU1212A, JKU1503A, JKU1504A, JKU1505A, JKU1506A, Exp 03/2021; JKU3313A & JKU3314A, Exp 08/2021. |
|---|
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-0320-2021%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.