BRIDGEWATER, N.J. – Sanofi is recalling hundreds of thousands of epinephrine injectors in North America used to treat severe allergic reactions because they may not deliver the correct amount of the life-saving drug.
The recall includes all Auvi-Q injections currently on the U.S. market, or roughly 490,000 packs of the devices, the company said in a press release. Most packs include two injectors.
The company’s Canadian subsidiary, Sanofi-aventis Canada, announced it was realling all Allerject products in Canada for the same reason.
“As of Oct 26, 2015, Sanofi US and Canada have received 26 reports of suspected device malfunctions from an estimated 2,784,000 units distributed in North America,” the Canadian company said in a news release.
“Specifically, in Canada, nine suspected device malfunctions were reported out of an estimated 492,000 units distributed.”
It said none of these device malfunction reports have been confirmed, but that patients had described symptoms of the underlying hypersensitivity reaction.
“No fatal outcomes have been reported among these cases,” it said.
Sanofi’s product competes with Mylan’s EpiPen, which is a staple of first-aid care. Both products are used to treat allergic reactions caused by insect bites and stings, foods, medicines or other substances.
About 200,000 people in the U.S. have Sanofi’s injector, according to company estimates.
“As this is a life-saving device, it is important that consumers understand not only to return the recalled device, but to get a replacement epinephrine auto-injector first,” said a company spokeswoman in an emailed statement.
Auvi-Q auto injectors were distributed throughout the U.S. through pharmacies, hospitals and wholesalers. The Paris-based company said it has kept the Food and Drug Administration abreast of the recall. The agency approved Auvi-Q in August 2012.
On the Web: www.Auvi-Q.com
— With files from The Canadian Press