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Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe ca...

FDA Recall #D-387-2014 — Class II — November 6, 2013

Recall #D-387-2014 Date: November 6, 2013 Classification: Class II Status: Terminated

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.

Recalling Firm

GlaxoSmithKline, LLC. — Zebulon, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

10,469 Systems

Distribution

Nationwide

Code Information

Lot#: C636293, Exp: 06/15

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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