Arranon — Class II drug recall D-068-2013
Terminated recall by GlaxoSmithKline, LLC., reported 2012-12-05, distributed nationwide. Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
| Recall number | D-068-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GlaxoSmithKline, LLC., Zebulon, NC, United States |
| Recall initiated | 2012-10-08 |
| Classified | 2012-11-27 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2014-09-11 |
| Distributed | Nationwide (US) |
| Quantity | 1,319 vials |
| Reason classes | specification failure |
| NDC | 00007-4401-06 |
| Lot numbers | 02/14, C533169, C536707, C538830 |
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 for recall
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-068-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.