Drug product
Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
D-1457-2016
Product summary
- Firm
- Actavis Inc
- Event
- Event 74702
- Status
- Terminated
- Classification
- Class II
- Quantity
- 167,152 bottles
- Official record key
drug-enforcement:D-1457-2016
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 # 3132593, 3132594, 3134420, 3134421,3134422, Exp. 02/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications