Class IIReported 2025-03-12

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

Recalled by Zydus Pharmaceuticals (USA) Inc

Reason for Recall

Failed Impurities/Degradation Specifications

Recall Number

D-0256-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-02-13

Reported

2025-03-12

Distribution

USA Nationwide

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.