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., Princeto

FDA recall notice · announced January 1, 2014 · Glaxosmithkline

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

Notes

Distribution: Nationwide
Lot/code information: Lot#: C636242, Exp: 06/15
Quantity: 9,743 cartridges
Status: Terminated
Products in this recall event:
- 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 (D-387-2014)
- 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, Res (D-388-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.