Auvi-Q (epinephrine injection, USP) Return & Reimbursement Process

Auvi-Q (epinephrine injection, USP) Recall FAQs

Sanofi US has voluntarily recalled all Auvi-Q® (epinephrine injection, USP) on the market through October 28, 2015. This includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers and covers lot numbers 2081278 through 3037230, which expire October 2015 through December 2016. The products have been found to potentially have inaccurate dosage delivery, which may include failure to deliver drug.

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. At the time of the recall Auvi-Q was distributed throughout the United States via wholesalers, pharmacies and hospitals.

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 click here and call 1-877-319-8963 or 1-866-726-6340 8 a.m. - 8 p.m. ET, Monday through Friday for information about how to return their Auvi-Q devices in lot numbers 2081278 through 3037230. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto-injectors with proof of purchase. In addition, if you purchased Auvi-Q at a cost that exceeds the cost of your replacement device, Sanofi will compensate you for the difference, with proof of original and replacement product purchases.

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 immediately 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.

The license and development agreement between Sanofi US and kaléo, (formerly Intelliject Inc.), the developer of Auvi-Q®(epinephrine injection, USP), has terminated. All U.S. and Canadian rights for this product have been returned to kaléo. Sanofi and kaléo are in the process of carrying out an orderly transition plan.

Adverse events or quality problems experienced with the use of this product should be reported either to Kaleo or to the FDA's MedWatch Program.

To report an adverse event to Kaleo, email kaleo@kai-research.com; fax 301-770-5608 , or call 844-828-8472 .

, or call . To report an adverse event to the FDA MedWatch Program: by fax at 1-800-FDA-0178 , by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at www.fda.gov/medwatch/report.htm

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.

Indication

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.

Important Safety Information

Auvi-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after use. Each Auvi-Q contains a single dose of epinephrine. Auvi-Q should only be injected into your outer thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY. If you accidentally inject Auvi-Q into any other part of your body, seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart related (cardiac) symptoms.

If you take certain medicines, you may develop serious life-threatening side effects from epinephrine. Be sure to tell your doctor all the medicines you take, especially medicines for asthma. Side effects may be increased in patients with certain medical conditions, or who take certain medicines. These include asthma, allergies, depression, thyroid disease, Parkinson's disease, diabetes, high blood pressure, and heart disease.

The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These side effects go away quickly, especially if you rest.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information and Patient Information.