Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery

Sanofi US is voluntarily recalling all Auvi-Q (epinephrine injection, USP). The recall involves all Auvi-Q 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. See the Press Release for product photos.

As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US 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 (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life-threatening condition.

To download the FDA's reporting form click here or call 1-800-332-1088 to request a reporting form. 

>> Click to read the MedWatch safety alert, including a link to the Press Release.