Sanofi-Aventis U.S. LLC recalls Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02)…

Recall date

October 28, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0872-2016

FDA classification

Class I

Brand / firm

Sanofi-Aventis U.S. LLC

Sold / distributed

Nationwide

Why it was recalled

Defective Delivery System; potential to have inaccurate dosage delivery

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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