Epinephrine Injection (Auvi-Q®) Recall Due to Dose Delivery Concerns
November 2, 2015
Sanofi US is recalling all marketed Auvi-Q auto-injectors due to concerns that dose delivery may be inaccurate. The recall affects both 0.15 mg and 0.3 mg doses. This includes lot numbers 2081278 through 3037230, with expiration dates from 10/2015 to 12/2016.
Epinephrine injection is used to treat severe allergic reactions, including anaphylaxis. Inadequate dosing may fail to properly treat allergic reactions and is considered potentially life-threatening. Currently 26 cases have been reported with suspected dose delivery malfunctions. No cases have been confirmed and no deaths have been reported.
Sanofi US is contacting wholesalers, pharmacies, and physician offices to arrange the return of recalled injectors. Patients with Auvi-Q injectors should contact their health care provider to obtain a prescription for a different brand of epinephrine injection. Sanofi US will reimburse consumers for the out-of-pocket costs of purchasing a different injector. Recalled Auvi-Q injectors should not be used unless no other epinephrine auto-injector is available. Patients should then seek immediate medical help after using Auvi-Q. Further information regarding the recall or reimbursement can be found on the Auvi-Q product website or by calling 1‑877‑319‑8963 or 1‑866‑726‑6340 Monday through Friday 8 a.m. to 8 p.m. ET.
- MedWatch Safety Alert – October 29, 2015
- Company Press Release
- Auvi-Q® Product Website
November 2, 2015; University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.