FDA Drug recall D-0392-2023
Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0
- FDA Drug
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0 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-0392-2023 |
| 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
Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-count bottles NDC 16729-090-15 UPC 3 16729 09015 5; c) 100-count bottles NDC 16729-090-01 UPC 3 16729 09001 8; d) 500-count bottles NDC 16729-090-16 UPC 3 16729 09016 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 | 316729090100 |
|---|---|
| upc | 316729090155 |
| upc | 316729090018 |
| upc | 316729090162 |
| ndc | 16729-090-10 |
| ndc | 16729-090-15 |
| ndc | 16729-090-01 |
| ndc | 16729-090-16 |
| ndc | 16729-090-17 |
| code_info | Batches: a) P2001383, Exp. Date 2/28/2023; P2004886, Exp. Date 8/31/2023; P2100853, Exp. Date 11/30/2023; P2101652, Exp…Batches: a) P2001383, Exp. Date 2/28/2023; P2004886, Exp. Date 8/31/2023; P2100853, Exp. Date 11/30/2023; P2101652, Exp. Date 2/29/2024; P2101821, Exp. Date 2/29/2024; P2102146, Exp. Date 3/31/2024; P2107270, Exp. Date 10/31/2024; P2107939, Exp. Date 10/31/2024; P2201491, Exp. Date 2/28/2025; b) P2001377, Exp. Date 2/28/2023; P2005673, Exp. Date 9/30/2023; P2005911, Exp. Date 10/31/2023; P2005878, Exp. Date 10/31/2023; P2006076, Exp. Date 10/31/2023; P2006110,Exp. Date 10/31/2023; P2006830, Exp. Date 11/30/2023; P2100639, Exp. Date 1/31/2024; P2100640, Exp. Date 1/31/2024; P2104208, Exp. Date 6/30/2024; P2105388, Exp. Date 7/31/2024; P2105387, Exp. Date 7/31/2024; P2200316, Exp. Date 12/31/2024; P2200318, Exp. Date 12/31/2024; P2200317, Exp. Date 12/31/2024; P2200319, Exp. Date 12/31/2024; P2200820, Exp. Date 1/31/2025; P2200822, Exp. Date 1/31/2025; P2201492, Exp. Date 2/28/2025; P2201493, Exp. Date 2/28/2025; P2201758, Exp. Date 2/28/2025; P2201759, Exp. Date 2/28/2025; P2202107, Ex |
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-0392-2023%22
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