Drug product
Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
D-0525-2023
Product summary
- Event
- Event 91952
- Status
- Ongoing
- Classification
- Class II
- Quantity
- a) 88 Bottles, b) 3 Bottles, c) 175 Bottles
- Official record key
drug-enforcement:D-0525-2023
Official wording
Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Code information: a) Lot: B0922G, Exp. Date: 5/31/2023, F0322G, Exp. Date: 7/25/2024, H2622M, Exp. Date: 8/31/2024, J1422B, K0722G, Exp. Date: 10/31/2024, L1922A, Exp. Date: 2/28/2025; b) Lot: F2922S, Exp. Date: 8/31/2023, H0322G Exp. Date: 7/31/2023; c) Lot: A1322I, Exp. Date: 3/31/2023, H1122C, Exp. Date: 8/31/2024.
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations