Class II
Drug Recall: 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,
Zydus Pharmaceuticals (USA) Inc · February 13, 2025
Reason for Recall
Failed Impurities/Degradation Specifications
Product Description
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
Distribution
USA Nationwide
States Affected
NATIONWIDE
Quantity Affected
1,893 vials
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0256-2025
Status: ongoing
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