Drug 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
D-068-2013
Product summary
- Event
- Event 63691
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,319 vials
- Official record key
drug-enforcement:D-068-2013
Official wording
Reason: Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Code information: Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.