FDA Drug recall D-0388-2023
Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1
- FDA Drug
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1 by Accord Healthcare, citing CGMP Deviations: recalling drug products following an FDA inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0388-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-02-07 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | PR |
Product
Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1; b) 1,000-count bottle NDC 16729-213-17 UPC 3 16729 21317 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Identifiers
| upc | 316729213011 |
|---|---|
| upc | 316729213172 |
| ndc | 16729-414-01 |
| ndc | 16729-414-17 |
| ndc | 16729-211-01 |
| ndc | 16729-211-17 |
| ndc | 16729-213-01 |
| ndc | 16729-213-17 |
| ndc | 16729-415-01 |
| ndc | 16729-415-17 |
| code_info | Batches: a) R2200352, Exp. Date 5/31/2024; R2200356, Exp. Date 8/31/2024; R2200357, Exp. Date 8/31/2024; R2200633, Exp.…Batches: a) R2200352, Exp. Date 5/31/2024; R2200356, Exp. Date 8/31/2024; R2200357, Exp. Date 8/31/2024; R2200633, Exp. Date 4/30/2025; R2200634, Exp. Date 4/30/2025; b) R2200677,Exp. Date 8/31/2024; R2200572,Exp. Date 4/30/2025; R2200571, Exp. Date 4/30/2025; R2200646, Exp. Date 4/30/2025; |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0388-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.