Sanofi Recalls Epinephrine Injection

Sanofi US and Sanofi Canada are voluntarily recalling all Auvi-Q / Allerject (epinephrine injection, USP). The recall involves all Auvi-Q / Allerject currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery.

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 is packaged with two active devices and one trainer device in a corrugate box. Auvi-Q was distributed throughout the U.S. via wholesalers, pharmacies and hospitals. All Auvi-Q is being recalled.

Sanofi Canada is recalling all Allerject (epinephrine injection, USP). Specifically, in Canada, 9 suspected device malfunctions were reported out of an estimated 492,000 units distributed. 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.