Class II · Moderate risk Ongoing
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…
Reason Failed Impurities/Degradation Specifications
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications
What was recalled
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
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- NDC code
- 70710-1839-1
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0256-2025
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Nelarabine recalls
See all
Class II · Moderate risk Terminated
Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC…
Reason Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
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