Drug recall D-0256-2025

Class II Ongoing reported Mar 12, 2025

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

Lots and codes

Lot: a) P300197, Exp. Aug-2025; P400113, Exp. May-26; b) P300169, Exp. Jun-2025; P400115, Exp. May-2026.

Recall details

Recalling firm
Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Quantity
1,893 vials
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
February 13, 2025

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