Multi event Drug Recall Enforcement Report Class II voluntary initiated by GlaxoSmithKline, LLC., originally initiated on 11-06-2013 for the 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 The product was recalled due to lack of assurance of sterility: a small number of pre-filled syringes may contain needles which protrude through the needle shield.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-387-2014 | 11-06-2013 | 01-01-2014 | Class II | 10,469 Systems | 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 | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. | Terminated |
| D-388-2014 | 11-06-2013 | 01-01-2014 | Class II | 9,743 cartridges | 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. | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. | Terminated |
Recalled Products
