Sanofi US has voluntarily recalled Auvi-Q epinephrine injection devices because the devices may not deliver an accurate dose, which can result in serious health consequences.
The recall involves all Auvi-Q devices currently on the market, both the 0.15 mg and 0.3 mg strengths for hospitals, retailers, and consumers. The recall includes lot numbers 2081278 through 3037230, with expirations from October 2015 through December 2016. The recalled products could potentially deliver an inaccurate dose, including failure to deliver the drug, according to the recall notice on the Food and Drug Administration (FDA) web site.
As of October 26, 2015, Sanofi had received 26 reports of suspected device malfunctions in the United States and Canada, though the company notes that none of these device malfunction reports have been confirmed.
Epinephrine injections like Auvi-Q are for patients experiencing anaphylaxis—a serious allergic reaction. Anaphylaxis is a potentially life-threatening condition and if the patient does not receive the intended epinephrine dose, the patient could suffer significant health consequences, including death. In the reports of suspected device malfunction, patients have described symptoms of the underlying hypersensitivity reaction. No deaths have been reported.
Auvi-Q (epinephrine injection, USP) is used to treat anaphylaxis in people who are at risk for or have a history of these reactions. Auvi-Q does not take the place of emergency medical care and Sanofi says users should seek immediate medical treatment after use. Auvi-Q is packaged with two active devices and one trainer device. Auvi-Q was distributed throughout the United States via wholesalers, pharmacies, and hospitals.
Sanofi US is notifying distributors and customers by letter, fax, email, and phone; this includes doctors, pharmacies, wholesalers and other customers. The company is arranging for the return and reimbursement for all recalled products.
Customers with questions about the recall can go to www.Auvi-Q.com or call 1-877-319-8963 or 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 email@example.com. Sanofi US will reimburse out-of-pocket cost for new epinephrine auto-injectors with proof of purchase. In addition, Sanofi will make up the difference to customers who purchased Auvi-Q at a cost greater than the cost of the replacement device. The customer must provide proof of purchase for the original and replacement products.
The company advises Auvi-Q customers to immediately contact a health care provider for a prescription for an alternate epinephrine auto-injector. In the event of a life-threatening allergic reaction, the patient should use the Auvi-Q device only if no other epinephrine auto-injector is available, and then call 911 or local medical emergency services. Customers should contact a physician if they experience any problems that may be related to this product.
The FDA encourages physicians and patients to report adverse reactions or quality problems experienced with the use of Auvi-Q to the MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm.