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.
Reported: January 1, 2014 Initiated: November 6, 2013 #D-388-2014
Product Description
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.
Details
- Recalling Firm
- GlaxoSmithKline, LLC.
- Units Affected
- 9,743 cartridges
- Distribution
- Nationwide
- Location
- Zebulon, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by GlaxoSmithKline, LLC.. Units affected: 9,743 cartridges.
Why was this product recalled? ▼
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 1, 2014. Severity: Moderate. Recall number: D-388-2014.
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