CLASS II Drug recall · Reported 1 Jan 2014 · FDA Enforcement Report
Imitrex STATdose System, Imitrex recalled by GlaxoSmithKline
GlaxoSmithKline is recalling Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled syringe, distributed nationwide in the US. The recall was initiated on 6 Nov 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-387-2014
- FDA event ID
- 66988
- Recalling firm
- GlaxoSmithKline, Zebulon, NC
- Brand
- Imitrex
- Manufacturer
- GlaxoSmithKline LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Nov 2013
- FDA classified
- 24 Dec 2013
- Reported
- 1 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Nov 2013 | Recall initiated by company | |
| 24 Dec 2013 | Classified by FDA | +48 days |
| 1 Jan 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Which lots are affected?
Lot#: C636293, Exp: 06/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 66988This product is part of a recall event; the main page for the event is Sumatriptan Succinate Injection recalled by GlaxoSmithKline.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sumatriptan Succinate Injection recalled by GlaxoSmithKline | GlaxoSmithKline | Sterility | Nationwide |
More recalls from GlaxoSmithKline
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|---|---|---|---|---|---|
| Drug | CLASS III | Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension recalled | GlaxoSmithKline | Other | Nationwide |
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| Drug | CLASS II | Ventolin HFA (albuterol sulfate) Inhalation recalled by GlaxoSmithKlineVentolin | GlaxoSmithKline | Potency & Assay | Nationwide |
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Other Sumatriptan recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sumatriptan Injection, USP, 6mg recalled by Mckesson Medical-Surgical | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sumatriptan Succinate Tablets, 100 mg, 9-of- use tablets recalledSumatriptan Succinate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sumatriptan Succinate Tablets, 50 mg recalledSumatriptan Succinate | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Sumatriptan Succinate Tablets, 100 mg recalled | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Sumatriptan Succinate Injection recalled by GlaxoSmithKline | GlaxoSmithKline | Sterility | Nationwide |