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
Reported: December 5, 2012 Initiated: October 8, 2012 #D-068-2013
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
Reason for Recall
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Details
- Recalling Firm
- GlaxoSmithKline, LLC.
- Units Affected
- 1,319 vials
- Distribution
- Nationwide
- Location
- Zebulon, NC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by GlaxoSmithKline, LLC.. Units affected: 1,319 vials.
Why was this product recalled? ▼
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 5, 2012. Severity: Moderate. Recall number: D-068-2013.
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