Daptomycin for Injection 500 mg per vial — Class II drug recall D-0382-2023
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-0382-2023 |
|---|---|
| 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 | 228,760 vials |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00316729435055 |
| NDC | 16729-0435, 16729-0435-05 |
| Lot numbers | R2101282, R2101600, R2200002, R2200028, R2200116, R2200142, R2200152, R2200165, R2200190, R2201042 |
| Expiration dates | 2023-09-30, 2024-11-30, 2024-12-31, 2025-01-31, 2025-07-31 |
Product
Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-435-05 UPC 3 16729 43505 5.
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-0382-2023. 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.