Recall D-0010-2025

US Class II Terminated · initiated 2024-10-01

Recalling firm

ACCORD HEALTHCARE, INC., NC

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

Reason for recall

Failed Impurities/Degradation Specifications.

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