Drug product
GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21
D-1276-2019
Product summary
- Event
- Event 82593
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,203 cartons (cartons of 30 individual unit doses)
- Official record key
drug-enforcement:D-1276-2019
Official wording
Reason: Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Code information: Lot # 181288, EXP 5/31/2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications