Metropolitan Boston Emergency Medical Service Council

25 B Street, Suite A Burlington, Massachusetts 01803

781-505-4367 (voice) | 781-272-6967 (fax)

MBEMSC MBEMSC MBEMSC MBEMSC MBEMSC MBEMSC

11/02/15

Voluntary Nationwide Recall of Auvi-Q(r) Epinephrine Auto-Injectors

Office of Emergency Medical Services

Department of Public Health                                                                                                               

Commonwealth of Massachusetts

Notice

FDA Notification: Voluntary Nationwide Recall of Auvi-Q® Epinephrine Auto-Injectors Due to Potential Inaccurate Dosage Delivery

 

The U.S. Food and Drug Administration (FDA) has issued a notification that 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 for hospitals, ambulance services, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. 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. Please note that 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 call 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. Customers may also email cs@sanofi.com. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto-injectors with proof of purchase. Read the FDA announcement of this voluntary recall, at: http://www.fda.gov/Safety/Recalls/ucm469980.htm