FDA Drug recall D-0476-2017
Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, N…
- FDA Drug
- Class II
- terminated
- Published 2017-02-22
On 2017-02-22 the FDA classified a Class II recall of Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, N… by Actavis, citing failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0476-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-30 |
| Published | 2017-02-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis |
| Distribution | US |
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
Reason
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Identifiers
| upc | 305910900304 |
|---|---|
| code_info | Lot #: 3134201, 3134202, Exp. 06/30/17; 3134319, Exp. 05/31/17; 3135246, Exp. 07/31/17; 3135247, 3136781, Exp. 08/31/1…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0476-2017%22
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