All Auvi-Q epinephrine auto-injectors are being recalled by Sanofi US due to 26 reports of hypersensitivity reactions in patients who have used the device. The issue suggests the products may have inaccurate dosage delivery. This recall affects all Auvi-Q products for hospitals, retailers and consumers.
Auvi-Q injections are used to treat life-threatening allergic reactions, known as anaphylaxis, in people who are at risk for or have a history of these reactions. If a patient experiencing anaphylaxis does not receive the intended dose of epinephrine, there could be serious health consequences, including death.
The recall affects all Auvi-Q products currently on the market, which includes both the 0.15 mg and the 0.3 mg strengths with the lot numbers 2299596 through 3037230. Auvi-Q is packaged with two active devices and one trainer device in a corrugate box. The products were distributed throughout the United States via wholesalers, pharmacies and hospitals.
Auvi-Q is one o f three epinephrine auto-injectors available in the United States. The other two are EpiPen and Adrenaclick. Consumers should immediately contact their doctors for a prescription for an alternative epinephrine auto-injector. In the event of a life threatening allergic reaction, patients should only use their Auvi-Q device if another epinephrine auto-injector is not available, and then call 911 or local medical emergency services, as indicated in the product’s instructions.
People with an Auvi-Q device are being asked to call 877‑319‑8963 or 866‑726‑6340, Monday through Friday, 8 a.m.-8 p.m. ET for information about how to return Auvi-Q. Details about reimbursement will be available on www.Auvi-Q.com as soon as they are available.
Any adverse effects involving Auvi-Q should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.