Recalls / Class I
Class ID-0872-2016
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, 0.3 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
- Affected lot / code info
- a) 2081278, 2113841, 2113842, 2144138, exp 10/2015; 2440675, exp 04/2016; 2506456, 2506460, 2546946, 2546947, exp 05/2016; 2620206, 2620207, 2659534, exp 06/2016; 2692111, 2692112, exp 07/2016; 2716517, 2719817, 2734079, 2734080, 2734081, 2778035, 2800128, exp 08/2016; 2800130, 2824828, 2824829, 2857516, 2867928, 2870928, 2867929, 2867930, 2883616, 2883617, exp 09/2016; 2883618, 2883619, 2974267, 2883620, 2945419, 2974269, exp 10/2016; 3026968, 3026969, exp 11/2016; 3026970, 3028227, 3032005, 3037217, 3037218, 3037219, exp 12/2016; b) 2299596, 03/2016
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
- 383,900 prefilled syringes
- 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-0872-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.