FDA Recall D-0873-2016

Sanofi-Aventis U.S. LLC · Bridgewater, NJ

Class I — life-threatening Terminated 3548 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

Lot / code: 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; 2883631, 2883632, exp 10/2016; 2883633, 2945429, 3028243, exp 11/2016; 3037230, 2966680, 2974276, 2974280, exp 12/2016; and b) 2525474, exp 05/2016

Quantity: 159,000 prefilled injectors

Reason for recall

Defective Delivery System; potential to have inaccurate dosage delivery

Recall record

Recall number: D-0873-2016
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide
Recall initiated: 2015-10-28
Classified by FDA Center: 2016-05-25
FDA published: 2016-06-01
Terminated: 2025-07-15
Recalling firm: Sanofi-Aventis U.S. LLC
Firm location: Bridgewater, NJ

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