Recall Auvi-Q

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 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.

 

Please return ALL Auvi‑Q devices. 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.

1. 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.

 

2. Call to Arrange for Auvi‑Q Return

 Call 877‑319‑8963 or 866‑726‑6340 to arrange for a return packet to be shipped to you. In approximately five days you will receive a prepaid mailing envelope, which will include a return form and a prepaid mailing label.

 

3. Return All of Your Auvi‑Q Devices

 Please return ALL Auvi‑Q devices. 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.

 

 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 Sanofi's recall processor.

 

Once your devices have been placed in the mail, please allow 30 days for processing and to receive your check.