FDA Drug recall D-0366-2023
Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 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 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 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-0366-2023 |
| 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 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-count bottle, NDC 16729-279-01, UPC 3 16729 27901 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 | 316729279109 |
|---|---|
| upc | 316729279017 |
| 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) P2004259, P2004260, P2004261, Exp. Date 7/31/2023; P2006799, P2101391, Exp. Date 11/30/2023; P2100826, Exp.…Batches: a) P2004259, P2004260, P2004261, Exp. Date 7/31/2023; P2006799, P2101391, Exp. Date 11/30/2023; P2100826, Exp. Date 1/31/2024; P2101320, Exp. Date 2/28/2024; P2102510, P2102409, P2102407, Exp. Date 3/31/2024; P2102410, Exp. Date 3/31/2024; P2105251, P2105252, P2105253, Exp. Date 7/31/2024; P2107404, P2107029, Exp. Date 10/31/2024; P2200260, P2200265, Exp. Date 12/31/2024; P2202067, P2202068, Exp. Date 3/31/2025; P2204239, Exp. Date 7/31/2025; b) P2006800 Exp. Date 11/30/2023; P2102141, Exp. Date 3/31/2024; P2104085, Exp. Date 6/30/2024; P2107031, P2107466, Exp. Date 10/31/2024; |
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-0366-2023%22
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