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Auvi-Q Auto-Injector Recall

October 31, 2015,

To our Valued ADC Patients,

On Thursday October 28, 2015, Sanofi US, the manufacturer of  the Auvi-Q (epinephrine auto injection device) voluntarily recalled all Auvi-Q auto injectors currently on the market (including both 0.15mg and 0.3mg strengths) due to possible inaccurate dosage delivery. The Lot numbers include every consecutive lot number beginning with 2299596 through 3037230. Upon receipt of this information, ADC reviewed our database which shows that you have been prescribed the Auvi-Q epinephrine auto injector device.

As of October 26, 2015, Sanofi US has received 26 reports of suspected device malfunctions in the US and Canada. None of these device malfunction reports have been confirmed. In these reports, patients have described continued symptoms of the underlying hypersensitivity reaction despite use of the drug. No fatal outcomes have been reported among these cases.

Sanofi US is notifying its distributors and customers who include doctors, pharmacies, wholesalers and other customers in the supply chain by letter, fax, email and phone calls and is arranging for return and reimbursement of all recalled products. Questions regarding this recall can be directed to  www.Auvi-Q.com or call 1-877-319-8963 or 1-866-726-6340 Monday through Friday 8 a.m. to 8 p.m. ET for information about how to return your Auvi-Q devices. Customers may also email cs@sanofi.com. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto-injectors with proof of purchase.

The recall contains further information on reporting adverse reactions or quality problems experienced with the use of this product. Incidents may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or fax.

  • Complete and submit the report Onlinefda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download from fda.gov/MedWatch/getforms.htmor call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

We suggest you contact your ADC healthcare provider for an alternate epinephrine auto-injector. In the event of a life-threatening allergic reaction before this replacement occurs, patients should use their on hand Auvi-Q device and then seek medical emergency services immediately. You should contact your physician if you have experienced any problems that may be related to taking or using this drug product.

Sincerely

Mynda Waldrop, M.D.
The Austin Diagnostic Clinic
Executive Medical Director