FDA-Drug2025-03-12Class II
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
Zydus Pharmaceuticals (USA) Inc
Hazard
Failed Impurities/Degradation Specifications
Sold states
USA Nationwide
Affected count
1,893 vials
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0256-2025Don't want to check this manually?
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