BRIDGEWATER, N.J., Oct. 29, 2015 /PRNewswire/ -- This post was authored by Dr. Paul Chew, Global Chief Medical Officer, Sanofi and was originally published on the Speaking of Sanofi blog on October 28, 2015: http://blog.sanofi.us/2015/10/28/sanofi-us-issues-voluntary-nationwide-recall-of-auvi-q-due-to-potential-inaccurate-dosage-delivery/
RECALL UPDATE: We have added an additional phone number for directions to return your device & reimbursement information. Please call EITHER 1-877-319-8963 OR 1-866-726-6340.
Please also contact your healthcare professional to obtain a new prescription for an alternate epinephrine auto-injector.
Sanofi US is voluntarily recalling all Auvi-Q® (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery.
If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life-threatening condition. As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. None of these device malfunction reports have been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases.
Please immediately contact your healthcare professional with any questions or concerns.
For more information, please review the below (UPDATED) video and/or read the entire press release: http://www.multivu.com/players/English/7673951-sanofi-auto-injector-recall/
Sanofi US Media Relations