Drug product
GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)
D-0020-2022
Product summary
- Event
- Event 88734
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,266 cartons
- Official record key
drug-enforcement:D-0020-2022
Official wording
Reason: Failed Dissolution Specifications: results were above specification.
Code information: Lot #: 194141, Exp. Date 03/31/2022
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications