Drug product
GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.
D-298-2013
Product summary
- Event
- Event 64960
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,373 bottles
- Official record key
drug-enforcement:D-298-2013
Official wording
Reason: Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.
Code information: Lot #: C0671212A, Exp 12/14
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.