Drug product
Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
D-0551-2023
Product summary
- Event
- Event 91944
- Status
- Ongoing
- Classification
- Class II
- Quantity
- a) 230 bottles; b) 22 bottles
- Official record key
drug-enforcement:D-0551-2023
Official wording
Reason: CGMP Deviations
Code information: a) Lot #: F106252201, Exp. Date 09/30/2024; F106252301, F106252303, Exp. Date 5/31/2025; F106252304, Exp. Date 07/31/2025 b) Lot #: F106252302, Exp. Date 07/31/2025
Distribution pattern: Nationwide with the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations