Could cause temporary or reversible harm; serious harm is unlikely.
CGMP Deviations: recalling drug products following an FDA inspection.
| Brand name | DOXAZOSIN |
| Generic name | DOXAZOSIN |
| Active ingredient(s) | DOXAZOSIN MESYLATE |
| Distributed by / for | Accord Healthcare, Inc., Durham, NC 27703 |
| NDC | 16729-415-01 |
| Full product label | Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets NDC 16729-415-17 UPC 3 16729 41517 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA |
| Recalling firm | Accord Healthcare, Inc. |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 31,116 bottles |
| Recall initiated | 2023-02-07 |
| Report date | 2023-03-08 |
| Recall completed | 2024-04-22 |
| Recall number | D-0389-2023 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Durham NC United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗