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

Recall Number: D-068-2013

Firm: GlaxoSmithKline, LLC.

Classification: Class II

Status: Terminated

Report Date: 20121205

Initiation Date: 20121008

Termination Date: 20140911

Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.

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