Recalls / Class I
Class ID-0873-2016
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- 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
Why it was recalled
Defective Delivery System; potential to have inaccurate dosage delivery
Recalling firm
- Firm
- Sanofi-Aventis U.S. LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 55 Corporate Dr, N/A, Bridgewater, New Jersey 08807-1265
Distribution
- Quantity
- 159,000 prefilled injectors
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-10-28
- FDA classified
- 2016-05-25
- Posted by FDA
- 2016-06-01
- Terminated
- 2025-07-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0873-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.