FDA recall D-388-2014

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-11-06

Report date

2014-01-01

Termination date

2014-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Zebulon, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-388-2014