FDA Drug recall D-387-2014
Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatript…
- FDA Drug
- Class II
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class II recall of Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatript… by Glaxosmithkline, citing lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-387-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-06 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Glaxosmithkline |
| Distribution | US |
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
Reason
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Identifiers
| ndc | 0173-0739-00 |
|---|---|
| ndc | 0173-0739-02 |
| ndc | 0173-0479-00 |
| ndc | 0173-0478-00 |
| code_info | Lot#: C636293, Exp: 06/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-387-2014%22
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