Sanofi U.S. is voluntarily recalling all Auvi-Q epinephrine auto-injectors due to suspected malfunctions that could deliver the wrong dose of medication.
The injectors are used to treat life-threatening allergic reactions, and a patient receiving an incorrect dose could face serious health consequences including death, according to an alert from the Food and Drug Administration.
Sanofi has received 26 unconfirmed reports of possible malfunctions as of Oct. 26. No deaths have been reported.
Although doctors may not be able to contact all of their patients directly, they should use social media and local media outlets to spread the word about the recall, according to Bridgette L. Jones, M.D., M.Sc., FAAAAI, FAAP, an allergy, asthma and immunology specialist with Children’s Mercy Hospitals and Clinics and a member of the AAP Committee on Drugs.
Patients who use Auvi-Q should ask their doctor for an alternate epinephrine auto-injector. They only should use Auvi-Q in the case of a life-threatening allergic reaction in which no other injector is immediately available and then call 911, the alert said.
Anyone experiencing adverse reactions after using Auvi-Q should contact their doctor and submit a report to the FDA at www.fda.gov/MedWatch/report or call 800-332-1088.
For instructions on returning their devices, Auvi-Q customers can contact the company at www.Auvi-Q.com, by email at firstname.lastname@example.org or by phone at 866-726-6340. Sanofi will reimburse customers for the out-of-pocket costs of purchasing a new auto-injector.