Recall: Auvi-Q for Emergency Allergic Reactions

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Manufacturer Sanofi has issued a voluntary recall of four lots of Auvi-Q (epinephrine), an injection used to treat life-threatening allergic reactions. Auvi-Q is one of the newer epinephrine injections available, with a device that has the ability to talk you through each step of the injection.

This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.

Who can recall a drug?

The manufacturer can voluntarily recall their medication or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled several lots of both strengths of the Auvi-Q injection: 0.15 mg/0.15 ml and 0.3 mg/0.3 ml.

Why has Auvi-Q been recalled?

The recall was initiated because some Auvi-Q pens are not delivering an accurate dose. The affected devices may not inject enough medication, or may fail to deliver the drug altogether. During a life-threatening allergic reaction, this could potentially result in death.

When was the recall initiated?

The affected lots of Auvi-Q were recalled by the manufacturer on October 30, 2015.

Are patients who have taken this medication being notified?

Yes. Although this is a class II recall and notification of patients is not necessary in all cases, Sanofi is notifying not just distributors but customers including doctors, pharmacies, and wholesalers.

Sanofi is also arranging for the return and reimbursement of any affected products. You can call 1-877-319-8963 or 1-866-726-6340, Monday through Friday, 8 am. to 8 pm eastern for information about how to return your recalled Auvi-Q.

Sanofi will reimburse you for the amount you pay at the pharmacy for a replacement. If the amount you paid for your recalled Auvi-Q is more than the cost of your replacement, you will be compensated for the difference if you can provide proof of your original and replacement purchases.

Which products were affected?

In this recall, lots 2081278 through 3037230 were affected. Auvi-Q from these lots will expire between October 2015 and December 2016.

Drug: Auvi-Q, 0.15 mg/0.15 mL
Packaging: carton containing 2 active devices, and 1 trainer device
National Drug Code (NDC): 64679-929-06

Drug: Auvi-Q, 0.3 mg/0.3 mL
Packaging: carton containing 2 active devices, and 1 trainer device
National Drug Code (NDC): 64679-927-01

What are some alternative options my doctor can prescribe instead of Auvi-Q?

There are several other epinephrine injections available, including EpiPen, EpiPen Jr, Adrenaclick, and epinephrine auto-injectors.

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