DOXAZOSIN MESYLATE Recall D-0389-2023
Description: 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
DOXAZOSIN MESYLATE Recall D-0389-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0389-2023 |
| Event ID | 91657 |
| Brand | DOXAZOSIN |
| Generic Name | DOXAZOSIN |
| Manufacturer | DOXAZOSIN |
| Original Package? | 1 |
| Active Substance | DOXAZOSIN MESYLATE |
| Drug Route | ORAL |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 31,116 bottles |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-211 16729-414 16729-213 |
| Drug UPC | 316729415019 316729415170 |
| Recall Initiation Date | 20230207 |
| Report Date | 20230308 |
| Classification Date | 20230302 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 86P6PQK0MU |
| Drug Application Number | ANDA202824 |
| Structured Product Labeling (SPL ID) | d9375d01-20cf-28aa-e053-2995a90a61fb |
| Structured Product Labeling (SPL Set ID) | 2830533c-ccdf-4401-b19c-763eeb1bc0a7 |
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