Drug product
Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
D-0552-2023
Product summary
- Event
- Event 91944
- Status
- Ongoing
- Classification
- Class II
- Quantity
- a) 198 bottles; b) 22 bottles
- Official record key
drug-enforcement:D-0552-2023
Official wording
Reason: CGMP Deviations
Code information: a) Lot #: F105692201, Exp. Date 09/30/2024; F105692203, Exp. Date 02/28/2025 b) Lot #: F105692202, Exp. Date 02/28/2025
Distribution pattern: Nationwide with the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations