FDA-Drug2012-12-05Class II

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

GlaxoSmithKline, LLC.
Hazard

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

Sold states
Nationwide
Affected count
1,319 vials
Manufactured in
1011 North Arendell Ave, N/A, Zebulon, NC, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-068-2013

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