FDAClass IIDecember 5, 2012

Arranon recall: Impurity Out of Spec

Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in…

Why was Arranon recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14

Product
Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in…
Recalling firm
GlaxoSmithKline, LLC.
Quantity
1,319 vials
Distribution
Nationwide
Recall date
December 5, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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