Drug product
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11
D-0202-2025
Product summary
- Event
- Event 96033
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,028 units (cartons of 30 individual unit doses)
- Official record key
drug-enforcement:D-0202-2025
Official wording
Reason: Failed Dissolution Specifications:
Code information: Lot # 1012910, Exp Date: 04/30/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications