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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Product Detail

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
Recall Number D-068-2013
Classification Class II
Code Info Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14
Product Distributed Qty 1,319 vials
Reason For Recall Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.

Event Detail

Event Id 63691
Product Type Drugs
Status Ongoing
Recalling Firm GlaxoSmithKline, LLC.
City Zebulon
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide