Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14
Why it was recalled
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Recalling firm
- Firm
- GlaxoSmithKline, LLC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1011 North Arendell Ave, N/A, Zebulon, North Carolina 27597-1217
Distribution
- Quantity
- 1,319 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-10-08
- FDA classified
- 2012-11-27
- Posted by FDA
- 2012-12-05
- Terminated
- 2014-09-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-068-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.