PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: June 1, 2016 Initiated: October 28, 2015 #D-0873-2016

Product Description

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

Reason for Recall

Defective Delivery System; potential to have inaccurate dosage delivery

Details

Recalling Firm
Sanofi-Aventis U.S. LLC
Units Affected
159,000 prefilled injectors
Distribution
Nationwide
Location
Bridgewater, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Sanofi-Aventis U.S. LLC. Units affected: 159,000 prefilled injectors.
Why was this product recalled?
Defective Delivery System; potential to have inaccurate dosage delivery
Which agency issued this recall?
This recall was issued by the FDA Drug on June 1, 2016. Severity: Critical. Recall number: D-0873-2016.