D-0010-2025 Class II Terminated
FDA drug recall D-0010-2025 was initiated by ACCORD HEALTHCARE, INC. on Oct 1, 2024 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications. The recall status is terminated (terminated Feb 23, 2026). Affected quantity: 11,214 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 23, 2024
- Initiation Date
- Oct 1, 2024
- Termination Date
- Feb 23, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,214 vials
Product 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
Reason for Recall
Failed Impurities/Degradation Specifications.
Distribution Pattern
Nationwide within the United States and PR
Code Information
Lot #: P2202009, Exp. Date: 03/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0010-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026