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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Detail

Product Description Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Singapore, NDC 0781-3173-07.
Recall Number D-388-2014
Classification Class II
Code Info Lot#: C636242, Exp: 06/15
Product Distributed Qty 9,743 cartridges
Reason For Recall Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

Event Detail

Event Id 66988
Product Type Drugs
Status Ongoing
Recalling Firm GlaxoSmithKline, LLC.
City Zebulon
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide