D-387-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 1, 2014
- Initiation Date
- November 6, 2013
- Termination Date
- August 20, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,469 Systems
Product Description
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
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 Pattern
Nationwide
Code Information
Lot#: C636293, Exp: 06/15