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
Product summary
- 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
Defective Delivery System; potential to have inaccurate dosage delivery