Reported Dec 5, 2012 · Terminated
Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle…
GlaxoSmithKline, LLC.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GlaxoSmithKline, LLC. · 1011 North Arendell Ave · Zebulon, NC · 27597-1217
Is this the product you have?
- 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
- Lot codes and dates
Lot # C536707 Exp 02/14C538830 Exp.02/14C533169 Exp. 02/14
- Amount recalled
- 1,319 vials
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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