Imitrex STATdose System — Class II drug recall D-387-2014
Terminated recall by GlaxoSmithKline, LLC., reported 2014-01-01, distributed nationwide. Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude throu
| Recall number | D-387-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GlaxoSmithKline, LLC., Zebulon, NC, United States |
| Recall initiated | 2013-11-06 |
| Classified | 2013-12-24 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2014-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 10,469 systems |
| Reason classes | sterility |
| NDC | 00173-0478, 00173-0478-00, 00173-0479, 00173-0479-00, 00173-0739, 00173-0739-00, 00173-0739-02 |
| Lot numbers | 06/15, C636293 |
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 for recall
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-387-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.