Drug product
Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4
D-0476-2017
Product summary
- Firm
- Actavis Inc
- Event
- Event 76406
- Status
- Terminated
- Classification
- Class II
- Quantity
- 499320 units
- Official record key
drug-enforcement:D-0476-2017
Official wording
Reason: Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Code information: Lot #: 3134201, 3134202, Exp. 06/30/17; 3134319, Exp. 05/31/17; 3135246, Exp. 07/31/17; 3135247, 3136781, Exp. 08/31/17; 3136782, Exp. 09/30/17; 3136903, 3136904, Exp.10/31/17; 3138250, Exp. 07/31/17; 3138968, Exp. 08/31/17; 3140000, Exp. 09/30/17
Distribution pattern: Nationwide in US
Derived failure modes
-
Potency or specification failure
out of specification