Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyJun 17, 2025 · 9 inspections, 1 with FDA action |
Recalls
- Feb 13, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications
Lots: Lot: a) P300072, P300073 Exp. Feb-2025; P300153, Exp. Jun-25; P300195, Exp. Aug-2025; P400014, P400017, Exp. Dec-2025; P400070, Exp. Feb-2026; P400112, May-2026; P400142, Exp. Jul-2026; b) P300068, Exp. Feb-2025; P300154, Exp.Jun-2025; P400015, P400018, Exp. Dec-2025; P400068, Exp. Feb-2026; P40011…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Nelarabine: every company that makes it
- Form
- injection, intravenous
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA215037
- On the market since
- Nov 17, 2021
- Package NDCs
70710-1726-170710-1726-8- Official label
- DailyMed (National Library of Medicine), updated Apr 7, 2025
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