FDA recall D-0872-2016

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

Reason for recall

Defective Delivery System; potential to have inaccurate dosage delivery

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-10-28

Report date

2016-06-01

Termination date

2025-07-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0872-2016