The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0872-2016·Announced 2016-06-01

Sanofi Recalls Auvi-Q Epinephrine Auto-Injectors Due to Defective Delivery System

Sanofi-Aventis is recalling Auvi-Q epinephrine auto-injectors because a defective delivery system may result in inaccurate dosage delivery.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as the defective delivery system poses a significant risk of inadequate treatment for a life-threatening condition.

Plain-English summary

Sanofi-Aventis U.S. LLC is recalling approximately 383,900 prefilled syringes of Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg. The recall involves two specific NDC configurations: (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00). The products were distributed nationwide.

The recall is being conducted because the auto-injectors have a defective delivery system that has the potential to deliver an inaccurate dosage of epinephrine. This defect could compromise the effectiveness of the medication during a medical emergency.

Consumers who have purchased these specific products should check their lot numbers and expiration dates against the list provided in the official recall notice. If the product matches the recalled lot numbers, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.

The recalled product

Product
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
Manufacturer
Sanofi-Aventis U.S. LLC
Category
Drug — Epinephrine Auto-Injector
Hazard
Affected units
383,900

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 (20)

  • a) 2081278
  • 2113841
  • 2113842
  • 2144138
  • exp 10/2015
  • 2440675
  • exp 04/2016
  • 2506456
  • 2506460
  • 2546946
  • 2546947
  • exp 05/2016
  • 2620206
  • 2620207
  • 2659534
  • exp 06/2016
  • 2692111
  • 2692112
  • exp 07/2016
  • 2716517

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Sanofi-Aventis U.S. 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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