Medication Monitor

Generic Name (Trade Name—Company)
October 29, 2015

Epinephrine injection

(Auvi-Q—Sanofi US)
Product recalled because of potential inaccurate dosage delivery

Sanofi US is voluntarily recalling all doses of epinephrine injection currently on the market under the trade name Auvi-Q, including both the 0.15-mg and 0.3-mg strengths for hospitals, retailers, and consumers. This includes lot numbers 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery. See the Press Release for product photos.

As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the United States 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.

If a patient experiencing a serious allergic reaction did not receive the intended dose, there could be significant health consequences, including death.

Auvi-Q is packaged with two active devices and one trainer device in a corrugated box. Auvi-Q was distributed throughout the United States via wholesalers, pharmacies, and hospitals.

Sanofi US is notifying its distributors and customers by letter, fax, e-mail, and phone calls and is arranging for return and reimbursement of all recalled products.