Sanofi Recalls Auvi-Q Due to Dosage Concerns

October 29, 2015

The company is voluntarily recalling the epinephrine injection, USP because of potential inaccurate dosage delivery.

 

FDA reports that Sanofi US is voluntarily recalling all Auvi-Q (epinephrine injection, USP), including both the 0.15-mg and 0.3-mg strengths for hospitals, retailers, and consumers. The company is recalling the product because of a possibility of inaccurate dosage delivery. Lots affected by the recall are number 2299596 through 3037230, which expire March 2016 through December 2016.

Auvi-Q is for the treatment of anaphylaxis, a life-threatening allergic reaction, and is packaged with two active devices and one trainer device in a corrugate box. It is distributed throughout the United States via wholesalers, pharmacies, and hospitals.

Sanofi has stated, in a press release, that, “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.” The company has received 26 unconfirmed reports of suspected device malfunctions in the US and Canada, as of October 26, 2015.

The company is recalling all Auvi-Q and is notifying its distributors and customers. Adverse reactions or quality problems may be reported to FDA's MedWatch Adverse Event Reporting program.

Source: FDA