Drug product
Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9
D-0517-2023
Product summary
- Event
- Event 91952
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17 Bottles
- Official record key
drug-enforcement:D-0517-2023
Official wording
Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Code information: Lot: D0122K, Exp. Date: 6/30/2024; Lot: I1422N, Exp. Date: 9/30/2024; Lot: I2721B, Exp. Date: 1/31/2024.
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations