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ACCORD HEALTHCARE, INC. recalls Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Ac

Recalled October 23, 2024 · FDA recall D-0010-2025 · ACCORD HEALTHCARE

Hazard
Failed Impurities/Degradation Specifications. · FDA Class II
Units
11,214 vials
Sold at
Nationwide within the United States and PR

Description

Failed Impurities/Degradation Specifications.

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
Manufacturer(s)
ACCORD HEALTHCARE, INC.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov