Drug 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
D-0010-2025
Product summary
- Event
- Event 95455
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,214 vials
- Official record key
drug-enforcement:D-0010-2025
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: Lot #: P2202009, Exp. Date: 03/2025
Distribution pattern: Nationwide within the United States and PR
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications