GlaxoSmithKline, LLC. recalls Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containin
Recalled January 1, 2014 · FDA recall D-387-2014 · GlaxoSmithKline
Hazard
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. · FDA Class II
Units
10,469 Systems
Sold at
Nationwide
Description
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
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
Manufacturer(s)
GlaxoSmithKline, LLC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →