We are reposting this information that was sent to us about the recall of Auvi-Q injectable epinephrine due to potential inaccurate dosing. All patients who have this device need to contact their health care professionals about getting a new prescription for an alternative epinephrine device such as EpiPen or Adrenaclick. Sanofi will reimburse patients later for their out of pocket expense from the purchase of their new device.
Below is the information from Sanofi:
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 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 firstname.lastname@example.org. 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
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 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.
If you have an Auvi-Q device, please contact your allergist or allergy doctor to prescribe you an alternative device.
Update: Sanofi announced today that the license and development agreement between Sanofi and kaléo, formerly Intelliject Inc., the developer of Auvi-Q® (epinephrine injection, USP), will terminate later this year. At that time, all U.S. and Canadian rights will be returned to kaléo. Sanofi is in discussions with kaléo on these terms and for an orderly transition plan. Kaléo will evaluate timing and options for bringing Auvi-Q back to market.
What this means is that Sanofi will no longer try and bring back Auvi-Q to the market, and kaleo will try to find another partner to bring this back if it desires. Many patients and allergists liked the convenience of Auvi-Q, but it seems this product may be lost forever. We will have further details if we hear any other news.