Class II · Moderate risk
Nelarabine Injection
Failed Impurities/Degradation Specifications
Arranon (nelarabine)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06
Affected NDC
0007-4401-06
Compare with the code on your package — it is the most precise check available.
Drug: Nelarabine
- Recalling firm
- GlaxoSmithKline, LLC.
- NDC code
- 0007-4401-06
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-068-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Nelarabine recalls
See all
Class II · Moderate risk
Nelarabine Injection
Failed Impurities/Degradation Specifications
Other recalls by GlaxoSmithKline, LLC.
All 2012 recalls
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