FDA recall D-068-2013

Product

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-10-08

Report date

2012-12-05

Termination date

2014-09-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Zebulon, NC, United States

Primary source

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