Devices may not deliver an accurate dose, which can result in serious health consequences. Sanofi US has announced the voluntary recall of all Auvi-Q epinephrine injections 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 have been found to potentially have inaccurate dosage delivery, which may include failure to deliver drug, according to the recall announcement.
If a patient experiencing a serious allergic reaction—anaphylaxis—does not receive the intended epinephrine dose, there could be significant health consequences, including death. Anaphylaxis is a potentially life-threatening condition.
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 these device malfunction reports have been confirmed. Patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported.
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 does not take the place of emergency medical care and the company 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 its distributors and customers, which includes doctors, pharmacies, wholesalers and other customers by letter, fax, email, and phone calls. 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 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 emailhref=”mailto:email@example.com”>firstname.lastname@example.org.
Sanofi US will reimburse out-of-pocket cost 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 that exceeds the cost of the replacement device. The customer must provide proof of purchase for the original and replacement products.
The company advises customers to immediately contact their health care provider
The company advises customers to immediately contact their 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 not available, and then call 911 or local medical emergency services.
Customers should contact a physician if they have experience any problems that may be related to taking or using this drug product.
The FDA encourages physicians and patients to report adverse reactions or quality problems experienced with the use of Auvi-Q MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm.