SANOFI US ISSUES VOLUNTARY NATIONWIDE RECALL OF ALL AUVI-Q® DUE TO POTENTIAL INACCURATE DOSAGE DELIVERY
This recall is being conducted with the knowledge of the U.S. Food & Drug Administration (FDA) due to potential inaccurate dosage delivery. The recall involves all Auvi-Q devices currently on the market and includes both the 0.15 mg and 0.3 mg strengths. As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the United States and Canada, none of which have been confirmed. No fatal outcomes have been reported. However, we are concerned that if a patient was experiencing anaphylaxis and ended up not receiving the intended dose, there could be significant implications due to the potentially life threatening nature of anaphylaxis.
Patients with questions regarding this recall can go to www.Auvi‑Q.com and call 1‑877‑319‑8963 or 1‑866‑726‑6340 Monday through Friday 8 a.m. to 8 p.m. ET for information about how to return their Auvi‑Q devices. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto‑injectors with proof of purchase. In addition, if you purchased Auvi‑Q at a cost that exceeds the cost of your replacement device, Sanofi will compensate you for the difference, with proof of original and replacement product purchases.
The Sanofi district manager has informed our office that the company will need to perform a thorough investigation as to the cause of the malfunction. Until this investigation is completed, Sanofi has told us Auvi-Q will be remain off the market.
Patients should immediately contact their healthcare provider (HCP) for a prescription for an alternate epinephrine auto‑injector device: EpiPen or EpiPen Jr.
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. Patients should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.
Holiday schedule at The Allergy & Asthma Clinic
In observance of Thanksgiving Day the Clinic will be closed Thursday November 26th and Friday November 27th. We will be open Saturday, November 28th, 9am-12pm for allergy shots.
In observance of Christmas the Clinic will be closed Thursday December 24th and Friday December 25th. We will be open on Saturday, December 26th, 9am-12pm for allergy shots.
In observance of New Year’s Day the Clinic will be open Thursday December 31st from 9am -12pm for allergy shots. The Clinic will be closed Friday January 1st. We will be open on Saturday January 2nd, 9am-12pm for allergy shots.
All of us at The Allergy & Asthma Clinic wish you and your loved ones a Happy Healthy Holiday Season!