Drug recall D-387-2014

Class II Terminated reported Jan 1, 2014

Product

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

Reason for recall

Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

Lots and codes

Lot#: C636293, Exp: 06/15

Recall details

Recalling firm
GlaxoSmithKline, LLC., Zebulon, NC
Quantity
10,469 Systems
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
November 6, 2013
Terminated
August 20, 2014

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