FDA Drug recall D-068-2013
Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709
- FDA Drug
- Class II
- terminated
- Published 2012-12-05
On 2012-12-05 the FDA classified a Class II recall of Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709 by Glaxosmithkline, citing impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-068-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-08 |
| Published | 2012-12-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Glaxosmithkline |
| Distribution | US |
Product
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
Reason
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Identifiers
| code_info | Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-068-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.