FDA Drug recall D-388-2014
Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumat…
- FDA Drug
- Class II
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class II recall of Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumat… by Glaxosmithkline, citing lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-388-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-06 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Glaxosmithkline |
| Distribution | US |
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
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Identifiers
| code_info | Lot#: C636242, Exp: 06/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-388-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.