Sanofi announced while presenting its third-quarter results that it is recalling 2.8 million units of its Auvi-Q auto-injectors because they may not deliver the correct amount of epinephrine to patients suffering from anaphylaxis.
The company said it had received 26 reports of malfunctions with the devices where they deliver inadequate doses of the life-saving drug, reported the Associated Press. A Sanofi spokesperson later chimed in, saying the devices potentially injected too little epinephrine or none at all.
It's noted that this malfunction could lead to "significant health consequences" for those using the injectors, however no fatalities have been reported thus far.
About 200,000 people in the U.S. and millions worldwide use Sanofi's injector to administer shots to themselves in case of threatening anaphylactic reactions, according to The Wall Street Journal.
The recall involves all Auvi-Q currently on the market in U.S. and Canada, including the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. The affected units have the lot numbers 2299596 through 3037230, which expire March 2016 through Dec. 2016.
Any consumers with the units affected by the recall are urged to call 1-866-726-6340 or visit the product's website for information on how to return the injector. They should also contact their health provider to get a prescription for an alternate device in the meantime. The company said it has kept the Food and Drug Administration abreast of the recall.
