Auvi-Q Epinephrine Auto-Injectors Recalled Due to Inaccurate Dosage Delivery

Sanofi is voluntarily recalling its epinephrine auto-injectors (Auvi-Q) because the devices could inaccurately deliver doses.

The recall involves all Auvi-Q products currently on the market—both the 0.15 mg and 0.3 mg strength injections. Lot numbers 2299596 through 3037230, which expire March 2016 through December 2016, are affected by this recall.

Sanofi has received 26 reports of suspected device malfunctions in the United States and Canada since October 26, 2015, though it noted in a press release that none of these reports have been confirmed.

Patients who reported adverse events described symptoms of an underlying hypersensitivity reaction. None of the cases were fatal.

However, if a patient does experience a serious allergic reaction, including anaphylaxis, and he or she does not receive an adequate dose of epinephrine, then the outcome could be fatal.

Sanofi is currently in the process of contacting its customers, including pharmacies, about this recall through letter, fax, email, and phone calls.

The manufacturer will reimburse pharmacies that bought these recalled products, Sanofi noted in a press release.

In emergency situations, pharmacists can inform their patients that they should only use their Auvi-Q device if another epinephrine auto-injector is not available. The patients should then call 911 or seek help from local emergency services.

Adverse events should be reported to FDA’s MedWatch Adverse Event Reporting program online, by mail, or via fax.