Class II
Terminated
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
- Company
- Accord Healthcare, Inc.
- Recall Initiated
- October 1, 2024
- Posted
- October 23, 2024
- Recall Number
- D-0010-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,214 vials
- Firm Location
- Raleigh, NC, United States
Reason for Recall
Failed Impurities/Degradation Specifications.
Distribution
Nationwide within the United States and PR
Lot / Code Info
Lot #: P2202009, Exp. Date: 03/2025
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