FDAFDA · Food and drugs·Recall number D-387-2014
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
Published January 1, 2014 · Recall initiated: November 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- IMITREX
- Manufacturer
- GlaxoSmithKline, LLC.
- Distributor
- Nationwide
- Lot
- Lot#: C636293, Exp: 06/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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