Drug Enforcement D-068-2013

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

Status

Terminated

Classification

Class II

Report Date

December 5, 2012

Termination Date

September 11, 2014

Product Information

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
Product quantity
1,319 vials
Reason for recall
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
GlaxoSmithKline, LLC.
Address
1011 North Arendell Ave, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-068-2013
Event ID
63691
Recall initiation date
October 8, 2012
Center classification date
November 27, 2012
Code info
Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14
More code info
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