CISPLATIN Recall D-0010-2025
Description: 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
CISPLATIN Recall D-0010-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0010-2025 |
| Event ID | 95455 |
| Brand | CISPLATIN |
| Generic Name | CISPLATIN |
| Manufacturer | CISPLATIN |
| Original Package? | 1 |
| Active Substance | CISPLATIN |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide within the United States and PR |
| Quantity | 11,214 vials |
| Recall Reason | Failed Impurities/Degradation Specifications. |
| Drug Classification | Class II |
| Drug Code Info | 20241023 |
| Product NDC | 16729-288 |
| Product NUI | N0000175413 N0000175073 |
| Pharma Class (EPC) | Platinum-based Drug [EPC] |
| Recall Initiation Date | 20241001 |
| Report Date | 20241023 |
| Classification Date | 20241011 |
| Address | 8041 Arco Corporate Dr Ste 200 Raleigh, NC 27617-2010 United States |
| Recalling Firm | ACCORD HEALTHCARE, INC. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | Q20Q21Q62J |
| Drug Application Number | ANDA206774 |
| Structured Product Labeling (SPL ID) | c43de769-d6d8-3bb9-e053-2995a90a5aa2 |
| Structured Product Labeling (SPL Set ID) | b2b029f5-0d7e-4e7f-accc-b722aec34c68 |
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