FDA Recall D-0872-2016

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, 0.3 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

Lot / code: 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, 2719817, 2734079, 2734080, 2734081, 2778035, 2800128, exp 08/2016; 2800130, 2824828, 2824829, 2857516, 2867928, 2870928, 2867929, 2867930, 2883616, 2883617, exp 09/2016; 2883618, 2883619, 2974267, 2883620, 2945419, 2974269, exp 10/2016; 3026968, 3026969, exp 11/2016; 3026970, 3028227, 3032005, 3037217, 3037218, 3037219, exp 12/2016; b) 2299596, 03/2016

Quantity: 383,900 prefilled syringes

Reason for recall

Defective Delivery System; potential to have inaccurate dosage delivery

Recall record

Recall number: D-0872-2016
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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