Imitrex Injection
FDA Recall NDC 0173-0739
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Imitrex (NDC 0173-0739). A significant event, classified as Class II, was initiated on Nov 06, 2013 by Glaxosmithkline Llc. The reported reason for this action was: "Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Nov 06, 2013
Jan 01, 2014
10,469 Systems
Recall Profile & Regulatory Data
Event ID
66988
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithKline, LLC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 20, 2014
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
Batch or Lot Expiration Information
Lot# : C636293, Exp: 06/15
Affected Packages Involved in this Recall
0173-0739-00Product
0173-0739-02Product
0173-0479-00Product
0173-0478-00Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
