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Recall Observatory FDA recall evidence

Drug 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

D-0873-2016

October 28, 2015

Class I

Product summary

Firm
Sanofi-Aventis U.S. LLC
Event
Event 72527
Status
Terminated
Classification
Class I
Quantity
159,000 prefilled injectors
Official record key
drug-enforcement:D-0873-2016

Official wording

Reason: Defective Delivery System; potential to have inaccurate dosage delivery

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Delivery System; potential to have inaccurate dosage delivery