Drug Maker, Sanofi is recalling thousands of Auvi-Q epinephrine autoinjectors as it has been reported that devices did not deliver an adequate dose of epinephrine to stop a severe allergic reaction.
Sanofi and the U.S. Food and Drug Administration announced the recall of Auvi-Q. It voluntarily recalled the devices after dose-dispensing problems were identified in internal quality reviews and after 26 reports from consumers in the U.S. and Canada.
AdvertisementIn Canada, Sanofi distributes the product under the name of Allerject and is recalling those devices, too. No deaths have been associated with the recall.
"What we found in our quality review is that there is a risk of not getting the full dose. Because of that risk and a low number of reports, we have felt as a precaution we would do this voluntary recall of all the Auvi-Q devices. We have been working very closely and proactively with (the FDA) on what we were going to do," said Dr. Paul Chew, Sanofi Global chief medical officer.
He said the recall affected approximately 490,000 Auvi-Q packs, with each pack consisting of two Auvi-Q devices and a training device. The company was able to retrieve some of the 26 devices consumers reported not working correctly but was not able to identify a malfunction in the device.
"We're moving as fast as we can to complete our investigation to see what the issue is. As a global chief medical officer, as a father, I understand that we have to have very safe and very effective products. So as a precaution we're doing that recall, a voluntary recall, as we further investigate these issues," chew added.