Dofetilide Capsules 500 mcg — Class II drug recall D-0385-2023
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-0385-2023 |
|---|---|
| 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 | 113,003 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00316729492126 |
| 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 | P2101482, P2101582, P2101661, P2101686, P2102581, P2102598, P2103623, P2103653, P2103670, P2104385, P2104386, P2104463, P2104472, P2104709, P2104714, P2200773, P2200797, P2200819, P2200831, P2201017, P2201056, P2201081, P2202611, P2202616, P2203467 |
| Expiration dates | 2023-02-28, 2023-04-30, 2023-05-31, 2023-06-30, 2023-12-31, 2024-01-31, 2024-12-31, 2025-04-30, 2025-05-31 |
Product
Dofetilide Capsules 500 mcg (0.5 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 16729-492-12 UPC 3 16729 49212 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-0385-2023. 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.