Sanofi ($SNY) has stopped manufacturing its epinephrine injection devices and is scrambling to retrieve nearly half a million from the U.S. and Canada because they may be giving the wrong dose. The recall came after Sanofi received more than two dozen reports of patients who had an adverse reaction after using their injector.
The injection devices are used for patients, often children, who have serious allergic reactions, or anaphylaxis. While the drugmaker said none of the "device malfunction reports have been confirmed" it warned that anaphylaxis is serious and can be fatal for someone who is having a reaction and who does not get the proper dose of the drug.
The French drugmaker said as of Monday, it had received 26 reports of "suspected device malfunctions," 17 in the U.S. and 9 in Canada. It said that it was recalling 492,000 packs, most of which contain two devices.
In the U.S., the product is marketed as Auvi-Q and in Canada as Allerject. The device, which Sanofi licenses from what used to be Intelliject, gives audio and visual cues that guide users step-by-step through the injection process. Intelliject last year changed its name to kaléo.
In a video that accompanies its announcement, Sanofi's Chief Medical Officer Dr. Paul Chew said consumers should first contact their doctors about getting a prescription for a different epinephrine injector. The FDA said in a MedWatch announcement that if patients have a serious allergic reaction they should only use their Auvi-Q device if another epinephrine auto-injector is not available, and then they should call 911 or local medical emergency services.
The recall came the day before the drugmaker issued its Q3 earnings report. In the earnings announcement, Sanofi said it expected the recall to cost the company an estimated €100 million ($109.4 million). It said it would account for the cost in its fourth quarter. Analysts say the recall should provide a boost for Mylan ($MYL), whose EpiPen product is the leader in the market.