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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 Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1 carrying case, Rx only, 6 mg, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in Singapore, NDC 0173-0479-00
Recall Number D-387-2014
Classification Class II
Code Info Lot#: C636293, Exp: 06/15
Product Distributed Qty 10,469 Systems
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