FDA Drug recall D-0370-2023
Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6
- FDA Drug
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6 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-0370-2023 |
| 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 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle, NDC 16729-283-01, UPC 3 16729 28301 4; 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 | 316729283106 |
|---|---|
| upc | 316729283014 |
| 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) P2005477, Exp. Date 9/30/2023; P2100002, Exp. Date 12/31/2023; P2101359 Exp. Date 2/28/2024; P2105409, Exp.…Batches: a) P2005477, Exp. Date 9/30/2023; P2100002, Exp. Date 12/31/2023; P2101359 Exp. Date 2/28/2024; P2105409, Exp. Date 7/31/2024; P2107447, Exp. Date 10/31/2024; P2203388 Exp. Date 5/31/2025; b) P2101859 Exp. Date 2/28/2023; P2107056, Exp. Date 10/31/2023; P2203066, Exp. Date 5/31/2024; P2206130, Exp. Date 8/31/2024; |
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-0370-2023%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.