Drug 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
D-0256-2025
Product summary
- Event
- Event 96291
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,893 vials
- Official record key
drug-enforcement:D-0256-2025
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot: a) P300197, Exp. Aug-2025; P400113, Exp. May-26; b) P300169, Exp. Jun-2025; P400115, Exp. May-2026.
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications