On Friday, October 30th, a voluntary recall was issued for all Auvi-Q epinephrine injectors on the market, due to issues with improper dosage. In some cases the injectors failed to deliver any epinephrine at all. These devices are used by people suffering acute allergic reactions, or anaphylaxis. In an emergency, the devices may fail to deliver necessary, life-saving medicine.
Who makes this product?
The product is manufactured by Sanofi US.
Which products are affected?
Any Auvi-Q on the market is affected by the recall, both the 0.15 mg dosage and the 0.30 mg dosage. Specifically, the products have lot numbers between 2081278 and 3037230 and expire between October 2015 and December 2016.
How widespread is the problem?
While not as popular at the Epipen, there are enough Auvi-Qs in consumers' hands that this recall warrants more attention that it is receiving in the press. It is being reported that there are just shy of 500,000 of these injectors out there at the moment.
What can be done about the product?
If you have an Auvi-Q injector, you are encouraged to contact Sanofi US at 1-800-981-2491. Sanofi recommends calling your physician immediately to get a replacement device. If you have experienced an adverse reaction to the product you can report it to the FDA by calling 1-800-332-1088.
What this means.
This is a much bigger deal than the sparse media coverage would indicate. Epinephrine injectors are real life-savers for people with severe allergies to things like peanuts and shellfish. They buy the necessary time so that those who are suffering from life-threatening allergic reactions can seek medical help. If these devices were not delivering enough of their life-saving medicine, or failed to deliver any at all, the consequences could be disastrous. I will be interested to see how Sanofi allowed so many of these defective products to get through its quality control process.
I know from my experience in the food service industry just how seriously one has to take severe allergies. When a customer informed me of an allergy, I would alert the chef and the front of the house management. The chef would in turn alert the entire kitchen staff and the customer's food would be prepared with extra vigilance, to prevent potentially killing someone. The mere mention of a food allergy would trigger a time-consuming, but absolutely necessary process, to ensure the customer's safety.
That is why it is so shocking, that a company that manufactures, what in essence is the same customer's last line of defense against death, would put out a defective product. The only saving grace in this whole incident, so far, is that there have not been any reported deaths, although there have been over two dozen malfunctions reported. That is either truly a miracle, or folks have not yet connected the dots. It strikes me as highly implausible that no one has been hurt by this product, given just how deadly acute allergic attacks can be. Hopefully, for the sake of those who have been prescribed this product, the good luck so far continues to hold up, although when dealing with severe allergies, hoping for luck is often a recipe for disaster.