FDA Drug recall D-0376-2023
BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1
- FDA Drug
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 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-0376-2023 |
| 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
BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) 500 Tablets NDC 16729-200-16 UPC 3 16729 20016 5; 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 | 316729200011 |
|---|---|
| upc | 316729200165 |
| ndc | 16729-203-12 |
| ndc | 16729-203-01 |
| ndc | 16729-203-59 |
| ndc | 16729-203-16 |
| ndc | 16729-203-17 |
| ndc | 16729-289-12 |
| ndc | 16729-289-01 |
| ndc | 16729-289-59 |
| ndc | 16729-289-16 |
| ndc | 16729-289-17 |
| ndc | 16729-200-01 |
| ndc | 16729-200-16 |
| ndc | 16729-200-17 |
| ndc | 16729-201-01 |
| ndc | 16729-201-16 |
| ndc | 16729-201-17 |
| ndc | 16729-202-01 |
| ndc | 16729-202-16 |
| ndc | 16729-202-17 |
| code_info | Batches: a) P2200530, Exp. Date 12/31/2024; b) P2105583, Exp. Date 6/30/2024; |
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-0376-2023%22
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