FDA Drug recall D-0426-2023
rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Int…
- FDA Drug
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Int… 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-0426-2023 |
| 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
rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-233-01, UPC 3 16729 23301 9
Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Identifiers
| upc | 316729233019 |
|---|---|
| ndc | 16729-232-01 |
| ndc | 16729-233-01 |
| ndc | 16729-234-01 |
| ndc | 16729-235-01 |
| ndc | 16729-236-01 |
| ndc | 16729-237-01 |
| ndc | 16729-238-01 |
| code_info | Batches: P2102133, P2102135, P2102136, Exp. Date 3/31/2023, P2104998, P2104997, P2104991, P2104992, P2104990, P2104993,…Batches: P2102133, P2102135, P2102136, Exp. Date 3/31/2023, P2104998, P2104997, P2104991, P2104992, P2104990, P2104993, P2105000, P2104999, P2105002, P2105001, Exp. Date 7/31/2023, P2106812, Exp. Date, 9/30/2023, P2200433, P2200434, P2200435, Exp. Date, 12/31/2023, P2202730, P2202729, Exp. Date 4/30/2024, P2203517, Exp. Date 5/31/2024 |
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-0426-2023%22
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