FDAClass IIJanuary 1, 2014

Imitrex STATdose System recall: Sterility Concern

Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for…

Why was Imitrex STATdose System recalled?

Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: C636293, Exp: 06/15

Product
Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for…
Recalling firm
GlaxoSmithKline, LLC.
Quantity
10,469 Systems
Distribution
Nationwide
Recall date
January 1, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls