FDA-Drug2014-01-01Class II
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
GlaxoSmithKline, LLC.
Hazard
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Sold states
Nationwide
Affected count
10,469 Systems
Manufactured in
1011 North Arendell Ave, N/A, Zebulon, NC, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-387-2014Don't want to check this manually?
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