Recall D-0255-2025

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 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ

Reason for recall

Failed Impurities/Degradation Specifications

← All recalls