# FDA recall D-387-2014

> **GlaxoSmithKline, LLC.** · Class II · drug recall initiated 2013-11-06.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-387-2014
- **Recalling firm:** GlaxoSmithKline, LLC.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-11-06
- **Report date:** 2014-01-01
- **Termination date:** 2014-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Zebulon, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-387-2014

## Citation

> AI Analytics. FDA recall D-387-2014. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-387-2014. Source: US FDA. Licensed CC0.

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