Auvi-Q is indicated for emergency treatment of allergic reactions (Type I) including anaphylaxis in patients who are at risk for or have a history of these reactions. Patients with anaphylaxis who do not receive the intended dose may experience significant health outcomes, including death.
The affected products include both the 0.15mg and 0.3mg strengths with Lot #2299596 through 3037230. Expiration dates range from March 2016 through December 2016. Auvi-Q is supplied as a package with two active devices and one trainer device.
The Company received 26 reports of suspected device malfunctions in the United States and Canada through October 26, 2015; no malfunction reports have been confirmed. Patients have described symptoms of the underlying hypersensitivity reactions in these reports but no fatalities have been reported.
Patients are recommended to contact their healthcare provider for an alternate epinephrine auto-injector prescription. Healthcare professionals are encouraged to report adverse events related to use of these products.
For more information call (866) 726-6340 or visit Auvi-Q.com.