Sanofi US and The American Academy of Allergy Asthma & Immunology have notified our office that Sanofi US has issued a voluntary nationwide recall of Auvi-Q® (epinephrine injection, USP) due to potential inaccurate dosage delivery.
Sanofi US is conducting this recall with the knowledge of the U.S. Food and Drug Administration. The concern is 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.
The recall covers all Auvi-Q units currently on the market in both the 0.15 mg and 0.3 mg strengths. This includes lot numbers 2299596 through 3037230, which expire March 2016 through December 2016, however, all Auvi-Q units are being recalled.
The manufacturer is urging patients to promptly contact their healthcare provider to arrange for a prescription for an alternate epinephrine auto-injector. The manufacturer is also advising patients to contact their healthcare provider if they experience any issues that may be related to using the product.
Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto-injectors with proof of purchase and there is a form you can print off their website to submit for reimbursement. Should you experience issues with coverage of a new epinephrine auto-injector in the meantime, please call your insurance company to discuss.
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 if they have experienced any problems that may be related to taking or using this drug product.
If you have questions related to the recall, you can visit Auvi‑Q.com and call 1‑866‑726‑6340 Monday through Friday (8 am to 8 pm ET) for assistance on how to return your devices.
Please contact our office so we can assist you by prescribing a new epinephrine auto-injector.
San Tan Allergy & Asthma