Auvi-Q Recall

Troubling news just in: ALL Auvi-Q autoinjectors currently issued are being voluntarily recalled by Sanofi because of potentially inaccurate dosing. Allergic individuals who have Auvi-Qs should still use them until a replacement can be obtained, but you should contact your doctor for a prescription for a different auto-injector as soon as possible.

“The recall involves all Auvi‑Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016.”

Sanofi has received 26 reports of suspected device malfunctions. No deaths are associated with these malfunctions. Sanofi is is arranging for return and reimbursement of all recalled products.

“Customers with questions regarding this recall can go to www.Auvi‑Q.com and call1‑866‑726‑6340 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.”

Update: Please call EITHER 1-877-319-8963 OR 1-866-726-6340. Sanofi US previously noted that, due to the high volume of calls, callers may have received a message that the line is down. They are asking consumers to please call back and try both numbers if this happens.

This sucks on all sorts of levels, folks. Sorry to have to report. Take care of yourselves!

“Sanofi US Issues Voluntary Nationwide Recall of 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 for hospitals, 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. 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 towww.Auvi‑Q.com and call1‑866‑726‑6340 Monday throughFriday 8 a.m. to 8 p.m. ET for information about how to return their Auvi‑Q devices. Customers may also emailcs@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.

Customers should immediately contact their healthcare provider (HCP) for a prescription for an alternate epinephrine auto‑injector. 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 or HCP if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online:www.fda.gov/medwatch/report.htm or by Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call1‑800‑332‑1088 to request a reporting form, then complete and return to the address on the pre‑addressed form, or submit by fax to 1‑800‑FDA‑0178

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.”

More Details from auvi-q.com

Additional Information

What is the potential or theoretical risk if the recalled product is administered to patients?

The current manufacturing issues are not related to the drug epinephrine. However, 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.

You say this is a voluntary recall, but did the FDA advise you to recall Auvi‑Q?

We discovered these issues as part of our routine manufacturer quality review and reported our findings to U.S. FDA. As a precautionary measure and in cooperation with the FDA, we are voluntarily recalling all Auvi‑Q currently in the market.

What should U.S. consumers do if they have this product?

People with an Auvi‑Q device are being asked to call 1‑866‑726‑6340, Monday through Friday, 8 a.m. – 8 p.m. ET for information about how to return Auvi‑Q. They may also email cs@sanofi.com. They should also immediately contact their healthcare providers for prescriptions for alternate epinephrine auto‑injectors. Details about reimbursement will be available on www.Auvi‑Q.com as soon as they are available.

Will patients have to pay for their replacement medication?

Initially, patients will need to pay for their replacement device. Sanofi US will reimburse patients for the full out‑of‑pocket cost when they receive a new epinephrine auto‑injector.

Have you alerted healthcare professionals?

Yes, we have actively been in contact with healthcare professionals.

What drug can be substituted as the replacement for Auvi‑Q?

Auvi‑Q is one of three epinephrine auto‑injectors available in the U.S. The other two are EpiPen® and Adrenaclick®.

What should a patient do if the Auvi‑Q product they have fails to work?

Please immediately call 911 or local medical emergency services for emergency medical attention. Any adverse event that may be related to the use of this product should be reported either to Sanofi US or to FDA’s MedWatch Program.

Do you expect to ultimately reintroduce this product in the U.S.? If so, when?

Our focus right now is on patient safety and resolving the issues. Once our investigation is complete and we have corrected any related issues, we will announce our future plans at a later date.