Sanofi U.S. has issued a voluntary recall involving of all its Auvi-Q epinephrine injection products. The company now believes that it’s possible for the said products to have inaccurate dosage delivery.
There have been 26 cases of suspected device malfunctions in the U.S. and Canada reported to Sanofi as of October 26. Moreover, no death resulting from possible incomplete dosage of the injectors has been reported.
The recall involves both Auvi-Q injections with 0.15 mg and 0.3 mg strengths sold to hospitals, retail stores and customers. The affected products have expiration dates that range between March 2016 and December 2016. Moreover, Sanofi says that the recall affects Auvi-Q injections with lot numbers 2299596 through 3037230.
The Auvi-Q epinephrine injection is used to treat a number of life-threatening allergic reactions or anaphylaxis. A package of Auvi-Q includes two active devices as well as one trainer device in corrugate box. Sanofi says that those who experience a serious allergic reaction and failed to receive the intended dose of epinephrine may suffer significant health consequences. Moreover, an incident like this may also result in death.
Sanofi says it is already notifying doctors, pharmacies, wholesalers and other customers abotu the recall. The company says it will provide reimbursement for out-of-pocket costs that have been incurred for the purchase of new epinephrine auto-injectors so long as a proof of purchase is shown.
Meanwhile, Sanofi says that should customers experience a life-threatening allergic reaction, they may use their Auvi-Q device if there is no other epinephrine auto-injector available. However, they must call 911 or local medical emergency services right away after using it.