Drug product
Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
D-0516-2023
Product summary
- Event
- Event 91952
- Status
- Ongoing
- Classification
- Class II
- Quantity
- a) 135 Bottles, b) 24 Bottles
- Official record key
drug-enforcement:D-0516-2023
Official wording
Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Code information: a) Lot: A1321V, D0221J, Exp. Date:8/31/2023; Lot: A1322J, Exp. Date: 5/31/2024; Lot: F0221Q, I0121E, I1021R, J1122D, Exp. Date: 10/31/2023; b) Lot: B0422J, Exp. Date: 5/31/2024; Lot: C1721K, Exp. Date: 8/31/2023; Lot: K1022Q, Exp. Date:11/30/2024.
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations