FDA-Drug2016-06-01Class I
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
Sanofi-Aventis U.S. LLC
Hazard
Defective Delivery System; potential to have inaccurate dosage delivery
Sold states
Nationwide
Affected count
159,000 prefilled injectors
Manufactured in
55 Corporate Dr, N/A, Bridgewater, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0873-2016Don't want to check this manually?
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