The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0873-2016·Announced 2016-06-01

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

Sanofi-Aventis is recalling 159,000 Auvi-Q epinephrine auto-injectors nationwide 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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5) due to the potential for serious adverse health consequences.

Plain-English summary

Sanofi-Aventis U.S. LLC is recalling 159,000 prefilled Auvi-Q (epinephrine injection, USP) Auto-Injectors, 0.15 mg, distributed nationwide. The recall involves specific lot numbers and expiration dates ranging from October 2015 to December 2016, as detailed in the agency's structured product information.

The recall was initiated because the product has a defective delivery system that poses a potential risk of inaccurate dosage delivery. This defect could affect the amount of epinephrine administered to the patient.

Consumers who have these specific products should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), 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
159,000

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) 2144144
  • exp 10/2015
  • 2469674
  • exp 04/2016
  • 2506492
  • 2546978
  • 2546979
  • exp 05/2016
  • 2654817
  • 2654818
  • exp 06/2016
  • 2692143
  • 2692144
  • exp 07/2016
  • 2719838
  • exp 08/2016
  • 2824845
  • 2891021
  • 2857530
  • exp 09/2016

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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