October 28, 2015
VOLUNTARY NATIONWIDE PRODUCT RECALL OF ALL LOTS OF AUVI-Q DUE TO POTENTIAL INACCURATE DOSAGE DELIVERY
RE: Auvi-Q® (epinephrine injection, USP)
Sanofi US announced today that the company is taking the precautionary measure of voluntarily recalling ALL Auvi-Q®(epinephrine injection, USP) currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes 491,298 packs distributed between January 13, 2015 and October 23, 2015 corresponding to lot numbers 2299596 through 3037230, which expire March 2016 through December 2016. Sanofi US initiated the recall due to, issues discovered during routine manufacturing quality review at a contract manufacturer. 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. As of October 26, 2015, Sanofi 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 symptoms of the underlying hypersensitivity reaction. 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. In the event of a life-threatening allergic reaction (anaphylaxis), patients should only use their Auvi-Q device if another epinephrine auto-injector is not available, and then call 911 or local emergency medical services immediately for emergency medical attention.
Sanofi US is committed to patient safety and the quality of Auvi-Q , and will continue to work closely with customers and regulatory authorities to resolve this issue in a timely manner. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
People with Auvi-Q devices should immediately contact their HCP for a prescription for an alternate epinephrine auto-injector. They can then call 1-866-726-6340 for information about how to return their Auvi-Q devices. Customers may also email email@example.com. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto-injectors with proof of purchase. Information and updates about the recall will be posted as they are available on www.Auvi-Q.com.
Auvi‑Q® (epinephrine injection, USP) is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to allergens, idiopathic and exercise-induced anaphylaxis. Auvi‑Q is intended for individuals with a history of anaphylaxis or who are at risk for anaphylactic reactions.
Important Safety Information
Auvi‑Q should ONLY be injected into the anterolateral aspect of the thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY.
Epinephrine should be administered with caution to patients with certain heart diseases, and in patients who are on medications that may sensitize the heart to arrhythmias, because it may precipitate or aggravate angina pectoris and produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported in patients with underlying cardiac disease or taking cardiac glycosides or diuretics. Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions. Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.
Auvi‑Q is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical or hospital care.
Please see accompanying full Prescribing Information.
Any adverse events that may be related to the use of these products should be reported either to Sanofi or to the FDA’s Med Watch Program.
- To report an adverse event to Sanofi US by phone at 1-800-666-1630, Option 2 or by fax at 1-908-203-7783.
- To report an adverse event to the FDA Med Watch Program by fax 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at www.fda.gov/medwatch/report.htm.