October 28, 2015: Voluntary Recall of All Auvi-Q® Manufactured By Sanofi US Due To Potential Inaccurate Dosage Delivery
Please return ALL Auvi-Q on the market through October 28, 2015. This includes both the 0.15 mg and 0.3 mg strengths in lot numbers 2081278 through 3037230. Sanofi US will reimburse patients for the out-of-pocket costs (the price you pay at the pharmacy) incurred to replace their unexpired Auvi-Q devices with a replacement epinephrine auto-injector. In addition, if you purchased Auvi-Q devices at a cost that exceeds the cost of your replacement devices, Sanofi will compensate you for the difference, with proof of original and replacement product purchases.
Below are the steps you should follow.
- Contact Your Healthcare Provider to Get a Prescription for a Replacement Device
You should immediately contact your healthcare provider for a prescription for an alternate epinephrine auto-injector. Keep the pharmacy receipt that details your out-of-pocket expense (the price you paid the pharmacy) for your new device.
- Go Online or Call to Arrange for Auvi-Q Return Of Devices in Affected Lot Numbers (2081278 through 3037230).
Go online anytime or call 1-877-319-8963 or 1-866-726-6340 8 a.m. – 8 p.m. ET, Monday through Friday to arrange for a return packet to be shipped to you. In approximately seven to ten days you will receive a prepaid mailing envelope, which will include a return form and a prepaid mailing label.
To request a return & reimbursement packet online click here.
- Return All of Your Auvi-Q Devices From the Affected Lot Numbers (2081278 through 3037230).
Please return ALL Auvi-Q devices from the affected lot numbers. Sanofi US will reimburse patients for the out-of-pocket costs (the price you pay at the pharmacy) incurred to replace their unexpired Auvi-Q devices with a replacement epinephrine auto-injector. In addition, if you purchased these Auvi-Q devices at a cost that exceeds the cost of your replacement devices, Sanofi will compensate you for the difference, with proof of original and replacement product purchases. You can obtain an original receipt at the point of purchase.
Attach the prepaid return mailing label to the outside of the return envelope and put the package in the mail with your Auvi-Q devices and proofs of purchase. The prepaid shipping label is pre-addressed to the Sanofi US recall processor. Once your devices have been placed in the mail, please allow about 45 days for processing and to receive your check.
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.