Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Imitrex STATdose System Recalled by GlaxoSmithKline, LLC. Due to Lack of Assurance of Sterility: A small number...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GlaxoSmithKline, LLC. directly.
Affected Products
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
Quantity: 10,469 Systems
Why Was This Recalled?
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GlaxoSmithKline, LLC.
GlaxoSmithKline, LLC. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report