Enforcement Report - Week of December 5, 2012
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Product Detail
| 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 |
|---|---|
| Recall Number | D-068-2013 |
| Classification | Class II |
| Code Info | Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14 |
| Product Distributed Qty | 1,319 vials |
| Reason For Recall | Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits. |
Event Detail
| Event Id | 63691 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | GlaxoSmithKline, LLC. |
| City | Zebulon |
| State | NC | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-08 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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