Reported Jun 1, 2016 · Terminated
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02)…
Sanofi-Aventis U.S. LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sanofi-Aventis U.S. LLC · 55 Corporate Dr · Bridgewater, NJ · 08807-1265
Is this the product you have?
- 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
- Lot codes and dates
a) 2081278211384121138422144138exp 10/20152440675exp 04/20162506456250646025469462546947exp 05/2016262020626202072659534exp 06/201626921112692112exp 07/20162716517271981727340792734080273408127780352800128exp 08/20162800130282482828248292857516286792828709282867929286793028836162883617exp 09/2016288361828836192974267288362029454192974269exp 10/201630269683026969exp 11/2016302697030282273032005303721730372183037219exp 12/2016b) 229959603/2016
- Amount recalled
- 383,900 prefilled syringes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Defective Delivery System; potential to have inaccurate dosage delivery
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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