The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-387-2014·Announced 2014-01-01

FDA Recalls Imitrex STATdose Systems Due to Sterility Concerns

GlaxoSmithKline is recalling 10,469 Imitrex STATdose Systems because some syringes may have needles protruding through the shield, compromising sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric. The hazard involves a potential breach of sterility in a subcutaneous injection device, which is a significant safety concern.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 10,469 units of Imitrex (sumatriptan) STATdose Systems. The recall was initiated by GlaxoSmithKline, LLC. The affected product is a prescription medication used for subcutaneous injection, specifically the 6 mg sumatriptan succinate formulation. The recall covers Lot C636293 with an expiration date of 06/15.

The reason for the recall is a lack of assurance of sterility. The source text indicates that a small number of the pre-filled syringes may contain needles that protrude through the needle shield. This defect poses a risk to the sterility of the injection system.

The affected products were distributed nationwide. Consumers and healthcare providers should stop using the recalled Imitrex STATdose Systems and contact their healthcare provider or GlaxoSmithKline for further instructions on how to return or dispose of the product.

The recalled product

Product
IMITREX (SUMATRIPTAN)
Brand
IMITREX
Manufacturer
GlaxoSmithKline, LLC.
Category
Drug — Injection
Hazard
Affected units
10,469

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot#: C636293
  • Exp: 06/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by GlaxoSmithKline, LLC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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