Drug 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.
D-1101-2023
Product summary
- Firm
- Ecometics, Inc.
- Event
- Event 92857
- Status
- Completed
- Classification
- Class II
- Quantity
- 92,967 vials
- Official record key
drug-enforcement:D-1101-2023
Official wording
Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.
Code information: Lot #: 2E144A, 2E157A, exp: 11/2023; 2E270A, exp: 3/2024; 2E300A, exp: 4/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations