Friday, October 30, 2015

Major Auvi-Q Recall

So some of you may have auvi-Qs and some may still be rocking the traditional epi-pens.  Regardless, either way it is SUPER important to stay on top of current news regarding these devices.

Sanofi just recalled a large number of auvi-Qs, so definitely check yours and make sure yours isn't one of the ones impacted by the recall.  The press release follows: 
Updated Press Release: Sanofi US Issues Voluntary Nationwide Recall of ALL Auvi‑Q® Due to Potential Inaccurate Dosage Delivery
Sanofi US is voluntarily recalling ALL Auvi‑Q® (epinephrine injection, USP). The recall involves ALL Auvi‑Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths. The Lot numbers include every consecutive lot number beginning with 2081278 through 3037230. The products have been found to potentially have inaccurate dosage delivery.
If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life‑threatening condition. As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. None of these device malfunction reports have been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases.
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. Auvi‑Q was distributed throughout the United States via wholesalers, pharmacies and hospitals. All Auvi‑Q is being recalled.
Sanofi US is notifying its distributors and customers who include 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 and call1‑877‑319‑8963 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.
Any adverse events or quality problems experienced with the use of this product should be reported either to Sanofi or to the FDA's MedWatch Program.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Sanofi US is committed to patient safety and the quality of Auvi‑Q, and will continue to work closely with customers and regulatory authorities to resolve this issue in a timely manner.

For frequently asked questions and a video from Sanofi US, please visit the "Additional Information" section on www.Auvi-Q.com.
If you have one, act quickly!  If you have an Epi-pen, there's an app that lets you register your devices by lot number and let's you know when they expire, plus you get a cute little backpack.  Either way sign up for emails regarding updates. 


Also, check out FARE, they're an awesome organization who keeps you updated on food allergies and current research, clinical trials, drugs that are coming out on the market, key topics from the latest conventions and all the big confreres at {http://www.foodallergy.org}

Stay safe! 

xx