Drug recall
Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each…
FDA recall event 66988 · Class II · GlaxoSmithKline, LLC.
Key facts
| Event ID | 66988 |
|---|---|
| Recall numbers | D-387-2014, D-388-2014 |
| Recalling firm | GlaxoSmithKline, LLC. |
| Product type | Drugs |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. |
| Initiation date | Nov 6, 2013 |
| Report date | Jan 1, 2014 |
| Termination date | Aug 20, 2014 |
| City | Zebulon |
| State | NC |
| Country | United States |
| FEI number | 1033964 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: