Sumatriptan Succinate Injection — Class II drug recall D-388-2014
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-388-2014 |
|---|---|
| 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 | 9,743 cartridges |
| Reason classes | sterility |
| NDC | 00781-3173-07 |
| Lot numbers | 06/15, C636242 |
Product
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.
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-388-2014. 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.