Important Drug Recall: Auvi-Q®

May 15, 2015 - On Oct. 28, 2015, Sanofi issued a consumer-level recall of all lots of Auvi-Q® (epinephrine) injection 0.15 mg and 0.30 mg. This recall was issued because the products have been found to potentially have inaccurate dosage delivery. If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life-threatening condition.

During a routine manufacturing quality review, issues with the device were discovered at a contract manufacturer that may potentially affect the delivery of the required amount of drug. As a precautionary measure, Sanofi has instructed its contract manufacturer to temporarily discontinue manufacturing and for all distribution to cease until all product issues are resolved.

We are working with our pharmacy benefits manager, CVS/caremark*, to contact patients and prescribers to advise them of this recall. We are encouraging patients who have Auvi-Q to contact their prescriber right away to obtain a prescription for an alternate epinephrine auto-injector.

Please consider any formulary requirements (located at www.carefirst.com/rx) or other prescribing limitations that your patients’ health plans may have in place and communicate any prescription changes directly to the pharmacy.

For more information about this recall, call Sanofi at 1-866-726-6340 or visit www.Auvi-Q.com. You may also call the United States Food and Drug Administration (FDA) consumer inquiry line at 1 888 INFO-FDA (1 888-463-6332) or visit www.fda.gov/Safety/Recalls/ucm469980.htm.

*CVS/caremark is an independent company that provides pharmacy benefit management services to CareFirst.