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

FDA recall notice · announced December 5, 2012 · Glaxosmithkline

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14
Quantity: 1,319 vials
Status: Terminated
Products in this recall event:
- 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 (D-068-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.