CLASS II Drug recall · Reported 1 Jan 2014 · FDA Enforcement Report
Sumatriptan Succinate Injection recalled by GlaxoSmithKline
GlaxoSmithKline is recalling Sumatriptan Succinate Injection, 6 mg For subcutaneous injection only, 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-388-2014
- FDA event ID
- 66988
- Recalling firm
- GlaxoSmithKline, Zebulon, NC
- 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
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, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Singapore, NDC 0781-3173-07.
Where it was distributed
Nationwide
Questions about this recall
Is Sumatriptan Succinate Injection, 6 mg For subcutaneous injection only recalled?
Yes. GlaxoSmithKline recalled Sumatriptan Succinate Injection, 6 mg For subcutaneous injection only on 6 Nov 2013. The recall is Class II and its status is Terminated. Recall number D-388-2014.
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#: C636242, 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Sumatriptan recalls
All 8| 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 USP for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |