D-0010-2025 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 23, 2024
- Initiation Date
- October 1, 2024
- Termination Date
- February 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