Recall D-0256-2025

US Class II Ongoing · initiated 2025-02-13

Recalling firm

Zydus Pharmaceuticals (USA) Inc, NJ

Product

Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ

Reason for recall

Failed Impurities/Degradation Specifications

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