BRIDGEWATER, N.J. — Sanofi U.S. announced this week that it is voluntarily recalling all of its Auvi-Q epinephrine auto-injector units due to suspected device malfunctions in the U.S. and Canada. The recall includes the 0.15 and 03-mg strength injectors, as well as the lot numbers 2081278 through 3037230.
“We’re doing this voluntary recall as a precaution and we have temporaroily stopped manufacturing. We take seriously the quality of our products as well as their safe and effective use,” Sanofi’s global chief medical officer Dr. Paul Chew said in a video.
Patients prescribed Auvi-Q should contact their doctor for a prescription for a new epinephrine auto-injector, Chew said. They should also call 877-319-8963 or 866-726-6340 in order to get information about returning the auto-injector and a reimbursement, if needed. If a patient paid more for an Auvi-Q than for a replacement auto-injector, Sanofi will reimburse the difference with proof of both purchases, and the company will reimburse patients their out-of-pocket costs for a new auto-injector with proof of purchase.
In response to the recall, Mylan, which makes the EpiPen epinephrine auto-injector, issued a statement noting that its products are not affected by the recall and are currently available for patients who need an auto-injecting epinephrine in case of anaphylaxis.