FDA Drug recall D-1101-2023
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065…
- FDA Drug
- Class II
- completed
- Published 2023-08-30
On 2023-08-30 the FDA classified a Class II recall of AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065… by Ecometics, citing CGMP Deviations: Products not manufactured under current good manufacturing practices.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1101-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-08-09 |
| Published | 2023-08-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ecometics |
| Distribution | US |
Product
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
Reason
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Identifiers
| code_info | Lot #: 2E144A, 2E157A, exp: 11/2023; 2E270A, exp: 3/2024; 2E300A, exp: 4/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1101-2023%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.