Sanofi recalls all of its Auvi-Q devices, undercutting its push to steal EpiPen market share

A couple of years ago, Sanofi ($SNY) released an epinephrine injection device that gives audio and visual cues for caregivers, hoping the high-tech pen could grab some of the sales from Mylan whose EpiPen product ruled the market. But Sanofi stumbled seriously on Wednesday when it issued a recall of all of its devices because they may be giving the wrong dose.

The French drugmaker, just hours before releasing its Q3 earnings said it was recalling 492,000 two-packs of its injection devices, marketed in the U.S. as Auvi-Q and in Canada as Allerject. The injection devices are used for patients, often children, who have serious allergic reactions, or anaphylaxis.

The drugmaker said as of Oct. 26 it had received 26 reports of "suspected device malfunctions," 17 in the U.S. and 9 Canada. 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.

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.

And that would be where Mylan ($MYL) comes in. Its EpiPen has ruled the market for years, allowing it to boost the sticker on the drug by more than 220% between 2007 and 2014 as it was routinely stocked in schools and other places. While it dominates, the Netherlands-based drugmaker stepped up its marketing of the device after Sanofi brought the Auvi-Q to market. It struck a deal with Disney ($DIS) to stock the pens in its theme parks and cruise ships and the two have even launched an informational website about anaphylaxis. Teva ($TEVA) also is working on copycat version it hopes will be substitutable for the EpiPen.

Sanofi said on Wednesday it had stopped manufacturing its auto injector and did not say when it might be returned to the market. It said in its earnings report that it expects to take a €100 million (109.4 million) hit in the fourth quarter to cover the cost of the recall.

- read the announcement
- get more in this release
- here's Sanofi's earnings release