Cisplatin Injection — Class II drug recall D-0010-2025
Terminated recall by ACCORD HEALTHCARE, INC., reported 2024-10-23, distributed nationwide. Failed Impurities/Degradation Specifications.
| Recall number | D-0010-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ACCORD HEALTHCARE, INC., Raleigh, NC, United States |
| Recall initiated | 2024-10-01 |
| Classified | 2024-10-11 |
| Reported by FDA | 2024-10-23 |
| Terminated | 2026-02-23 |
| Distributed | Nationwide (US) |
| Quantity | 11,214 vials |
| Reason classes | specification failure |
| NDC | 16729-0288, 16729-0288-11, 16729-0288-38 |
| Lot numbers | P2202009 |
| Expiration dates | 2025-03 |
Product
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38
Reason for recall
Failed Impurities/Degradation Specifications.
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-0010-2025. 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.