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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot#: C636242, Exp: 06/15 Class II Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. 9,743 cartridges D-388-2014
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 Lot#: C636293, Exp: 06/15 Class II Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. 10,469 Systems D-387-2014
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