Drug 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
D-387-2014
Product summary
- Event
- Event 66988
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,469 Systems
- Official record key
drug-enforcement:D-387-2014
Official wording
Reason: Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Code information: Lot#: C636293, Exp: 06/15
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility