FDA-Drug2014-01-01Class II

Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Singapore, NDC 0781-3173-07.

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
9,743 cartridges
Manufactured in
1011 North Arendell Ave, N/A, Zebulon, NC, United States
Products
Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Singapore, NDC 0781-3173-07.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-388-2014

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