Sanofi is voluntarily recalling all Auvi-Q currently on the market over concerns of potentially inaccurate dosage delivery.
As of Oct. 26, Sanofi has received 26 reports of suspected device malfunctions in the U.S. and Canada, according to a press release.
None of these device malfunction reports have been confirmed, and no fatalities have been reported. In these reports, patients have described symptoms of the underlying hypersensitivity reaction.
The recall includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers, and consumers. This includes lot numbers 2081278 through 3037230, which expire October 2015 through December 2016.
Auvi-Q was distributed throughout the United States via wholesalers, pharmacies, and hospitals. Sanofi US is notifying its distributors and customers, who include doctors, pharmacies, wholesalers and other customers in the supply chain, by letter, fax, email and phone calls, and is arranging for return and reimbursement of all recalled products.