rOPINIRole Tablets USP 1 mg* — Class II drug recall D-0427-2023
Terminated recall by Accord Healthcare, Inc., reported 2023-03-08, distributed in PR. CGMP Deviations: recalling drug products following an FDA inspection.
| Recall number | D-0427-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accord Healthcare, Inc., Durham, NC, United States |
| Recall initiated | 2023-02-07 |
| Classified | 2023-03-02 |
| Reported by FDA | 2023-03-08 |
| Terminated | 2024-04-22 |
| Distributed | PR |
| Countries outside the US | CA |
| Quantity | 104,945 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00316729234016 |
| NDC | 16729-0232, 16729-0232-01, 16729-0233, 16729-0233-01, 16729-0234, 16729-0234-01, 16729-0235, 16729-0235-01, 16729-0236, 16729-0236-01, 16729-0237, 16729-0237-01, 16729-0238, 16729-0238-01 |
| Lot numbers | P2103544, P2106128, P2106129, P2106130, P2106131, P2106132, P2106133, P2107662, P2107663, P2107664, P2203543 |
| Expiration dates | 2023-05-31, 2023-08-31, 2023-11-30, 2024-05-31 |
Product
rOPINIRole Tablets USP 1 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 16729-234-01, UPC 3 16729 23401 6
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0427-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.