Auvi-Q Epinephrine Auto-injectors Recalled Because They May Deliver Inaccurate Dose

In a recall announcement posted on the Food and Drug Administration (FDA) web site, Sanofi US says it has voluntarily recalled all Auvi-Q epinephrine auto-injectors because the devices may not deliver an accurate epinephrine dose.

The recall involves all Auvi-Q currently on the market, both the 0.15 mg and 0.3 mg strengths for hospitals, retailers, and consumers. The lot numbers are 2081278 through 3037230, with expiration dates from October 2015 through December 2016. According to the recall notice, the auto-injectors could deliver an inaccurate dose or could fail to deliver the drug. 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.

As of October 26, 2015, Sanofi said it had received 26 reports of suspected Auvi-Q malfunctions in the United States and Canada. The company notes that none of these device malfunction reports have been confirmed.

Auvi-Q is an emergency treatment for people experiencing anaphylaxis—a serious allergic reaction. Anaphylaxis is a potentially life-threatening condition with symptoms including skin reactions (hives, itching, and flushed or pale skin); constriction of the airways; swollen tongue or throat, which can cause wheezing and trouble breathing; weak and rapid pulse; nausea, vomiting or diarrhea; dizziness or fainting, according to the Mayo Clinic. If someone experiencing anaphylaxis does not receive a sufficient epinephrine dose, he or she could suffer significant health consequences, including death. In the reports of the suspected device malfunction, patients described symptoms of the underlying allergic reaction. To date, no deaths have been reported.

Auvi-Q (epinephrine injection, USP) is prescribed for people who are at risk for anaphylaxis or have a history of such reactions. Auvi-Q does not take the place of emergency medical care and the user should seek immediate medical treatment after use.

Sanofi US is notifying distributors and customers by letter, fax, email, and phone. The company is arranging for the return and reimbursement for all recalled products.

Customers can contact Sanofi at 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 the company at cs@sanofi.com. Sanofi US will reimburse out-of-pocket cost for new epinephrine auto-injectors with proof of purchase. Sanofi will make up the difference to customers who paid more for Auvi-Q than for the replacement device. The customer must provide proof of purchase for the original and replacement products.

Sanofi advises Auvi-Q customers to 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 Auvi-Q auto-injector only if no other epinephrine auto-injector is available. The user should call 911 or local medical emergency services after using Auvi-Q. Customers should contact a physician if they experience any problems that may be related to Auvi-Q.

The FDA asks physicians and patients to report adverse reactions or quality problems with Auvi-Q to the MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm.

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from Parker Waichman http://www.yourlawyer.com/blog/auvi-q-epinephrine-auto-injectors-recalled-because-they-may-deliver-inaccurate-dose/