Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith K...
FDA Recall #D-068-2013 — Class II — October 8, 2012
Product Description
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.
Recalling Firm
GlaxoSmithKline, LLC. — Zebulon, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,319 vials
Distribution
Nationwide
Code Information
Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated