Drug product
Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
D-0527-2023
Product summary
- Event
- Event 91952
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 Bottles
- Official record key
drug-enforcement:D-0527-2023
Official wording
Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Code information: Lot: H1221Z, I0121J, J0622X, Exp 10/31/2023.
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations