FDA Drug recall D-0369-2023
Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9
- FDA Drug
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9 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-0369-2023 |
| 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
Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100-count bottle, NDC 16729-282-01, UPC 3 16729 28201 7; 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 | 316729282109 |
|---|---|
| upc | 316729282017 |
| ndc | 16729-278-10 |
| ndc | 16729-278-01 |
| ndc | 16729-278-16 |
| ndc | 16729-278-46 |
| ndc | 16729-279-10 |
| ndc | 16729-279-01 |
| ndc | 16729-279-16 |
| ndc | 16729-279-46 |
| ndc | 16729-280-10 |
| ndc | 16729-280-01 |
| ndc | 16729-280-16 |
| ndc | 16729-280-46 |
| ndc | 16729-281-10 |
| ndc | 16729-281-01 |
| ndc | 16729-281-16 |
| ndc | 16729-281-46 |
| ndc | 16729-282-10 |
| ndc | 16729-282-01 |
| ndc | 16729-282-16 |
| ndc | 16729-282-46 |
| ndc | 16729-283-10 |
| ndc | 16729-283-01 |
| ndc | 16729-283-16 |
| ndc | 16729-283-46 |
| code_info | Batches: a) P2100787, P2100788, Exp. Date 1/31/2024; P2104736, Exp. Date 6/30/2024; P2105492, Exp. Date 8/31/2024; P210…Batches: a) P2100787, P2100788, Exp. Date 1/31/2024; P2104736, Exp. Date 6/30/2024; P2105492, Exp. Date 8/31/2024; P2107172, P2107175, Exp. Date 10/31/2024; P2203043, Exp. Date 5/31/2025; b) P2104086 Exp. Date 6/30/2024, P2205370 Exp. 8/31/2025; |
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-0369-2023%22
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