Important Recall Notice: All Auvi-Q Epinephrine Auto-Injectors

Sanofi US Issues Voluntary Nationwide Recall of Auvi-Q®
Due to Potential Inaccurate Dosage Delivery

 

[Press Release]

 

Company Contact

Karen Sutherland

Tel. : +1 908-989-0726

Email : USMediaRelations@Sanofi.com

 

 

Bridgewater, N.J. - October 30, 2015 - Sanofi US is voluntarily recalling all Auvi-Q® (epinephrine injection, USP).The recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot numbers 2081278 through 3037230, which expire October 2015 through December 2016.The products have been found to potentially have inaccurate dosage delivery, which may include failure to deliver drug.


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.


Auvi-Q (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions. Auvi-Q is packaged with two active devices and one trainer device in a corrugate box. Auvi-Q was distributed throughout the United States via wholesalers, pharmacies and hospitals. All Auvi-Q is being recalled.

 auvi-q-recall

 

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.

 

Customers with questions regarding this recall can go to www.Auvi-Q.com and call 1-866-726-6340 or 1-877-319-8963 Monday through Friday 8 a.m. to 8 p.m. ET for information about how to return their 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.

 

Customers should immediately contact their healthcare provider (HCP) for a prescription for an alternate epinephrine auto-injector. 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 medical emergency services. Customers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.


Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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

 

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.

 

Important Safety Information
Auvi-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after use. Each Auvi-Q contains a single dose of epinephrine. Auvi-Q should only be injected into your outer thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY. If you accidentally inject Auvi-Q into any other part of your body, seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

 

If you take certain medicines, you may develop serious life-threatening side effects from epinephrine. Be sure to tell your doctor about all the medicines you take, especially medicines for asthma. Side effects may be increased in patients with certain medical conditions, or who take certain medicines. These include asthma, allergies, depression, thyroid disease, Parkinson’s disease, diabetes, high blood pressure, and heart disease.

 

The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These side effects go away quickly, especially if you rest.

 

You are encouraged to report negative side effects of prescription drugs.

In the US, contact the FDA by visiting www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please click here for Full Prescribing Information.

 

About Sanofi US

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

 

Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US. For more information on Sanofi US, please visit http://www.sanofi.us and http://www.news.sanofi.us/social-media or call 1-800-981-2491.

 

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

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This has been vey confusing, as to whether ALL Auvi-Q's are under the recall up to this point.  Many on the Sanofi Lines were told it was only limited to Auvi-Q's with Expiration dates of March 2016 and later, with the lot numbers described for those Auvi-Q's. I myself received a return phone call from the FDA confirming exactly the same information, and that those Auvi-Q's with exp. dates of February 2016 and before should be fine.

 

NOW SANOFI HAS REMOVED ALL DOUBT:  ALL AUVI-Q AUTO-INJECTORS ARE IN THE RECALL, WITH EXPIRATION DATES OF OCTOBER 2015 THROUGH DECEMBER 2016, and has expanded the list of lot numbers recalled to include all of them, on their updated Recall Notice, available on their website.

 

Thank you all for investigating this issue and sharing your results with the rest of us here!

 

My pharmacist at Rite Aid collected multiple packs of unused Auvi-Q's from me which I collected from my son's school, both of his homes, and another caregiver, for exchange.  I called our insurance and was able to get the usual coverage for 3 sets of EpiPens this month vs. the usual 1 pkg every 30 days, with my doctor's prescription.  I appreciate that, but want to add that it is only because I have my own Rx for EpiPens for my bee sting allergy, which I refilled yesterday, was I able to have enough auto-injectors to give out to the rest of the locations my son absolutely had to have them in.  I sincerely hope other families who need sets of these auto-injectors available at multiple locations are able to get them right away.  I myself could not have afforded to pay outright the enitre cost of these multiple replacement sets of EpiPens without insurance agreeing to offer extra coverage for these right away. In other words, if I had to wait for reimbursement from Sanofi and/ or pay completely out-of-pocket for more than ! replacement pack, I could not pay the price and keep him reasonably prepared to treat anaphylaxis.

 

Thanks Again!

My Target pharmacy called me yesterday to make sure that I knew about the recall and she told me that they were asking their patients to bring their recalled Auvi-Qs to the pharmacy when they pick up their new prescription.  I was able to fill one Epipen, Jr. prescription and my second will be filled when their truck arrives (they were completely out of Epipen, Jrs. and only had one Epipen on the shelf).  

 

I don't know if all pharmacies are calling their patients and handling the recall for them or not, but I really appreciated their calling to make sure that I knew about it.   I was able to use the Epipen savings card to get my Epipen for free and didn't have to wait on the phone to talk to a representative or do any paperwork to do the recall.  Hopefully this will be an option for some other people too.

I called waited 45 mins. Gave my name for the Return/ Reimbursement packet and asked about Oct 15 to Feb 16 Expiration dates and was told they were fine.   So not sure if I trust it after y'all were told it is ALL DEVICES.

I got one set of replacements. Called my insurance company and they over ruled to allow me to get another set tomorrow (pharmacy only had one set on the shelf).  They allowed because need at least two sets at school since one set is locked in office and one set is in my child and roams with her. Will have to replace others one set a month.  My purse Epi-Pen expires 12/15. Just bad timing.

Thanks for the update... I spoke with someone from Sanofi last evening and she told me my previous pens (not included in the recalled lot numbers) would be safe. However, she also indicated that they were only then getting detailed information and couldn't tell me more than the press release had stated.  It made me nervous using an earlier device considering Sanofi has inferred that they are not exactly sure what is occurring with the dosing, thus making me concerned that ALL devices are suspect.  I figure better safe than sorry and won't use any of my AuviQ's regardless. 

 

 

Update: We have confirmed this recall affects ALL Auvi-Q devices. It doesn't matter what lot number.

 

Update: Sanofi confirms the phone number in the press release is correct. The lines have been overwhelmed by calls. They are adding more staff and opening more lines. The number will remain the same: 1-866-726-6340 Monday through Friday 8 a.m. to 8 p.m. ET

Hello, fellow parents! I just hung up with the service agent I reached via the 800 # listed on the press release. I waited 40 minutes in queue first. They are sending a recall packet, which arrives in 5-10 biz days. Meanwhile, I can go to pharmacy and buy (out-of-pocket) a new epi (not Auvi-Q, as they are all being taken off shelves), and I'll be reimbursed the cost after I send in proof-of-purchase along with my recalled Auvi-Qs.

Amber, we will contact Sanofi to clarify.  I can see why there's confusion.  We were told all Auvi-Qs and the FDA recall says all Auvi-Qs. But the lot numbers in the recall don't include all Auvi-Qs that people have.

 

Thanks!

Lynda

Lynda, It says all Auvi-Q's currently on the market and gives the numbers and dates, ones issued with March 2016+ expiration dates.  Some of our Auvi-Q's, which are NOT currently on the market, expire in October 2015 and February 2016.  These auvi-Q's are not referred to by Sanofi, the FDA, etc, thus the ambiguity.

 

I will am in process of getting some EpiPens to replace all of our Auvi-Q's, but I cannot imagine being eligible to replace them all immediately, and certainly do not expect Insurance or Sanofi is going to cover replacing more than 1 pack per month at most.  So it would be good to know if some older Auvi-Q's could be relied upon for a tempory fill-in until we get enough EpiPens to replace all of them, in all locations.  I am not going to dispose of these older auto-injectors until I am sure.

 

Thanks!

 

Amber Houk

Leslie, I hope you are correct about the Auvi-Q's with exp. dates sooner than March being fine to use.  Another food allergy organization, Snack Safely, is posting that ALL Auvi-Q's are being recalled. There is no information regarding this question from Sanofi, etc., that I can find.

 

Hopefully we will get more answers today, and there will be ways to ensure all can obtain the epinephrine they need  to replace these Auvi-Q's, right away.

Amber B., I think any auvi-q that expires before March and which has a lot number that is not within the numbers listed is perfectly safe and I would use those first in case of an emergency.

 

I have the same concern that there will be a run on Epipens and they may be hard to get.  I contacted my pediatrician and allergist for refills as soon as I saw the recall.

So after reading the info from Sanofi regarding this recall, I am wondering if we are to assume the Auvi-Q's with Expiration dates prior to March 2016 are considered perfectly fine.

 

 

I also am concerned about replacing all of the sets of Auvi-Q's we need right now, some kept at school, my ex-husbands house, other care providers, and extra on-hand when we are traveling in areas remote from emergency medical care, as well as for those times our primary pack of meds gets misplaced, frozen, or "fried," which does happen more than once a year.  This is why we get our prescription refilled many months of the year. I am not optimistic patients can trade in multiple packs of unexpired Auvi-Q's for other auto-injectors right away, in order to receive more than one pack per month.

 

I guess in the future we will try to get prescriptions of more than one brand of Auto-injector and have them on-hand in case of another recall like this.  Never thought about a situation like this.

 

Kudos to Sanofi for taking action.  Hoping more information on these issues will be available very soon.  I did email questions to Sanofi last night.

 

Thanks for the update!  I have one Epipen, Jr., so I am hoping to bring it back and forth to school without any hassle until I can get a refill.  I think I will keep both Epipens and Auvi-Qs in the future in case this happens again.

I received the 'No longer in service' recording as well to the number posted.  I pulled the number listed in the AuviQ pamphlet (800-633-1610) and connected without issue.  Be warned... I spent 1.25 hours on hold only to be spoon fed the same information we read in the notice above.  However, they are sending me a shipping label to return my AuviQs, and told me to include any receipts for the new Epi's in the package for reimbursement.  Unfortunately, they just don't have any confirmed information to pass along about the dosing issue to date.

I called the number listed on the post as well about 45 minutes ago.  I received a recorded message and then was asked to leave my name and number, which I did.  I'm sure the company is working quickly to figure out how to get all the devices returned.

I've heard many others reporting getting a message about the number being disconnected.  But others are reporting it works.  It may just be that their circuits are overloaded with everyone calling right now.

The phone number listed in this article :  1-866-726-6340 

is not in service. I called 4 times and got a recorded message each time saying this number is no longer in service.

 

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Kids With Food Allergies
A Division of the Asthma and Allergy Foundation of America
1235 South Clark Street Suite 305, Arlington, VA 22202
Phone: 1-800-7-ASTHMA (1.800.727.8462)
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