Drug product
GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21
D-0520-2017
Product summary
- Event
- Event 76636
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,393 cartons (581,790 extended release tablets)
- Official record key
drug-enforcement:D-0520-2017
Official wording
Reason: Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Code information: Lot #160133, 160549 Exp. 08/17 Lot #162006; Exp. 09/17 Lot #163348A, 163348B; Exp. 10/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications