Dofetilide Capsules — Class II drug recall D-0383-2023
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-0383-2023 |
|---|---|
| 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 | 37,790 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00316729490122 |
| NDC | 16729-0490, 16729-0490-12, 16729-0490-59, 16729-0491, 16729-0491-12, 16729-0491-59, 16729-0492, 16729-0492-12, 16729-0492-59 |
| Lot numbers | P2101480, P2102579, P2102596, P2104707, P2104711, P2200771, P2200795, P2200829, P2202608, P2203463, P2203492, P2205373, P2205412 |
| Expiration dates | 2023-02-28, 2023-04-30, 2023-06-30, 2023-12-31, 2025-04-30, 2025-05-31, 2025-08-31 |
Product
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-490-12 UPC 3 16729 49012 2
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-0383-2023. 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.