D-068-2013 Class II Terminated
FDA drug recall D-068-2013 was initiated by GlaxoSmithKline, LLC. on Oct 8, 2012 and is designated Class II. Reason for recall: Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits. The recall status is terminated (terminated Sep 11, 2014). Affected quantity: 1,319 vials.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 5, 2012
- Initiation Date
- Oct 8, 2012
- Termination Date
- Sep 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,319 vials
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.
Distribution pattern
Nationwide
Code information
Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-068-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026