Recalls / Class II
Class IID-387-2014
Product
Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1 carrying case, Rx only, 6 mg, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in Singapore, NDC 0173-0479-00
- Brand name
- Imitrex
- Generic name
- Sumatriptan
- Active ingredient
- Sumatriptan Succinate
- Route
- Subcutaneous
- NDCs
- 0173-0478, 0173-0739, 0173-0479
- FDA application
- NDA020080
- Affected lot / code info
- Lot#: C636293, Exp: 06/15
Why it was recalled
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Recalling firm
- Firm
- GlaxoSmithKline, LLC.
- Manufacturer
- GlaxoSmithKline LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1011 North Arendell Ave, N/A, Zebulon, North Carolina 27597-1217
Distribution
- Quantity
- 10,469 Systems
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-11-06
- FDA classified
- 2013-12-24
- Posted by FDA
- 2014-01-01
- Terminated
- 2014-08-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-387-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.