DETROIT – Sanofi US is voluntarily recalling all Auvi-Q (epinephrine injection, USP), including both the 0.15 mg and 0.3 mg strengths, for hospitals, retailers and consumers, because the products may have inaccurate dosage delivery.
If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) takes a wrong dose, there could be significant health consequences, including death, because anaphylaxis is a potentially life?threatening condition.
The recall includes lot numbers 2299596 through 3037230, which expire March 2016 through Dec. 2016.
As of Monday, Sanofi had received 26 reports of suspected device malfunctions in the U.S. and Canada. None of these device malfunction reports have been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. There haven't been any deaths reported.
Auvi?Q (epinephrine injection, USP) is used to treat life?threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions. Auvi?Q is packaged with two active devices and one trainer device in a corrugate box and was distributed throughout the United States via wholesalers, pharmacies and hospitals.
Sanofi US is notifying its distributors and customers, including doctors, pharmacies, wholesalers and other customers in the supply chain, by letter, fax, email and phone calls and is arranging for return and reimbursement of all recalled products.
Customers with questions regarding this recall can go to www.Auvi?Q.com or call 1?866?726?6340 Monday through Friday from 8 a.m. to 8 p.m. You can also find information about how to return the Auvi?Q devices.
Customers may also email cs@sanofi.com for reimbursement for out-of-pocket costs as a result of the purchase of new epinephrine auto?injectors, with proof of purchase.
Customers should immediately contact their health care provider for a prescription for an alternate epinephrine auto?injector. In the event of a life?threatening allergic reaction (anaphylaxis), 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. Customers should contact their physician or health care provider if they have experienced any problems that may be related to taking this drug.
Adverse reactions or quality problems experienced with the use of this product can be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.