Sanofi is recalling hundreds of thousands of epinephrine injectors 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.
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.
The French drug and vaccine maker said it has received 26 reports of malfunctions with the injectors. None involved patient deaths, according to the company announcement.
Consumers can call 1-866-726-6340 or visit the product’s website for information on how to return the injector. They should also contact their health provider to get a prescription for an alternate device.
“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.