CLASS II Drug recall · Reported 5 Dec 2012 · FDA Enforcement Report
Arranon (nelarabine) Injection 5mg/mL Vials recalled by GlaxoSmithKline
GlaxoSmithKline is recalling Arranon (nelarabine) Injection 5mg/mL Vials, distributed nationwide in the US. The recall was initiated on 8 Oct 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-068-2013
- FDA event ID
- 63691
- Recalling firm
- GlaxoSmithKline, Zebulon, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Oct 2012
- FDA classified
- 27 Nov 2012
- Reported
- 5 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Oct 2012 | Recall initiated by company | |
| 27 Nov 2012 | Classified by FDA | +50 days |
| 5 Dec 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Which lots are affected?
Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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