Sanofi recalls epinephrine injector devices from U.S. and Canada

Sanofi ($SNY) is recalling all of its epinephrine injector devices from the U.S. and Canada, a potentially costly setback for the company as it competes for market share with rival drugmaker Mylan ($MYL).

The French drugmaker voluntarily recalled its Auvi-Q products after getting 26 reports that the devices potentially delivered too little or no epinephrine, possibly resulting in "significant health consequences" for patients, the company told The Wall Street Journal. So far, no deaths have been linked to the recall. And Sanofi said that it would reimburse patients' out-of-pocket costs for replacement devices.

The move represents a costly blow for the company, which will have to shell out $150 million for the recall. Sanofi already faces competition for its injectors from Mylan and its EpiPen device. EpiPen had the first-to-market advantage and has not wasted any time gobbling up share, holding about 90% of the market for epinephrine injectors, according to the WSJ story.

But Auvi-Q has gained in popularity since making its market debut in 2013, the newspaper points out, with its small size and vocal instructions for use attracting consumers. EpiPen and Auvi-Q both sell for more than $400 a pop for a packet of two injectors, and both need to be replaced in one year.

The recall is "disconcerting," Tonya Winders, president and CEO of the Allergy and Asthma Network, told the WSJ. About 25% of patients routinely carry epinephrine injectors, the newspaper points out, and more than 20 million Americans are at risk for life-threatening allergic reactions. Until Sanofi replaces the product, the company and Winders are advising patients to use it in an emergency. "Any epinephrine is better than no epinephrine," Winders said.

Sanofi's recall also comes about a year after it inked a deal with injectable technology provider Unilife ($UNIS) to make the company its sole provider of cartridge-based wearable injectors over the next 15 years. The wearable injectors market is expected to yield $8 billion in sales by 2025, Unilife said at the time, and the deal helps both parties cash in on a growing market.

- read the WSJ story (sub. req.)