10/28/15 – All Auvi-Q Epinephrine Autoinjectors Recalled

Today Sanofi US announced a large scale recall of their .15 and .3 mg epinephrine autoinjectors.  A few folks subscribe to this blog because of the pricing and expiration date updates I’ve provided about autoinjectors so I wanted to link to their announcement right away: http://www.news.sanofi.us/2015-10-28-Sanofi-US-Issues-Voluntary-Nationwide-Recall-of-Auvi-Q-Due-to-Potential-Inaccurate-Dosage-Delivery

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I’m disturbed that I learned about this via twitter even though I’ve registered for emails from Sanofi about the Auvi-Q and received an email from them on October 22 reminding me to use discount cards before they expire.

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Questions folks have right now include:

  • What autoinjector do we get in the meantime if we’re returning recalled ones?
  • Do we need a new prescription?
  • Will Sanofi reimburse for replacements and if so, do they have to be of the same brand or can they be for a competitor model?
  • Will the failures as reported be confirmed and if so, how?
  • Will the expense and public relations fallout mean even higher prices for Auvi-Q in the future?
  • Are expired Auvi-Q models affected or those only within the current expiration date range?

Also, the wording of the announcement has a lot of people confused because it talks about specific expiration dates and then also says all injectors on the market are impacted.  The announcement also talks about hypersensitivity which is odd wording.

You could view the recall as being in an abundance of caution and therefore showing how sensitive Sanofi is being to consumers or you can wonder about the timing and the lack of actual clear instructions for how to handle the issue.  People who have relied on EpiPens may be saying “told you so” while those who embraced Auvi-Q may be wondering about making a switch, we still don’t know enough at this point except that how this is handled going forward will certainly impact consumer perceptions.

The costs of replacing medication, between new doctor’s appointments for prescriptions, potentially missing work or school to sort matters out, and more are factors that Sanofi can’t control.  I have preferred the Auvi-Q in form and function since it was released but will be sending my daughter to school tomorrow with a set of EpiPens.  The sheer expense of a mid-year replacement (ie, replacing the EpiPen with an Auvi-Q if new batches ship) make reverting back to the Auvi-Q another year away for us.

No matter what take we have as the story develops, safety is always a priority.  Though I’m no medical expert or professional, my standard operating procedure for food allergies is: Avoid allergens and respond appropriately in the event of known ingestion or a reaction.  Always carry two autoinjectors and practice your allergy action plan.  If all you have is an Auvi-Q in the event of a reaction before you can replace it, use it.  The same goes for using an expired autoinjector – if it is all there is and there’s no time to waste, use what you can safely use.

12 thoughts on “10/28/15 – All Auvi-Q Epinephrine Autoinjectors Recalled

    1. Will do! Certainly curious to see how they handle having not notified purchasers (or, from reports I’m hearing from folks, pharmacies) immediately.

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    1. The recall appears to involve Canada for the Allerject as well so I’m curious about how the 26 reports are distributed regionally.

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  1. Sanofi’s Facebook page has several statements regarding this issue, in at least one they claim that they will be reimbursing if units are returned to them. Here is the phone number: 1-866-726-6340 Due to high volume of calls, it might be necessary to call back a few times in order to get through.

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  2. Some of your questions have been answered in a Q&A on the auvi-q site, have you seen that? What I’m wondering is if Auvi-Q will survive this. We’ve only ever used EpiPen but I like the idea of Auvi-Q, and of having competition in the Epinephrine market.

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    1. Yes, I’ve seen the answers they’ve listed, thank you Eileen! People who have called the support number have received different answers so I know there may be concerns at this point about how it will actually play out given the inconsistent messaging. I agree about competition, the unfortunate thing is that both EpiPen and Auvi-Q seem to have been increasing prices in tandem. When I re-filled last month the price difference given my combo of cash pay prices and the discount card made for a $3 difference between the two types.

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  3. I learned about the recall from FARE in an email yesterday. I could not get through on the number given and tried again today. After waiting on hold for about 45 minutes I was asked for name and address so they could send a box to send back the recalled devices and that they will reimburse you for the new injectors with proof of purchase and not what you paid for the AUVI Q originally. My understanding is that you need to send new injector receipts in the box as well. The people answering the phones are a 3rd party not Sanolfi (or that is what I was told) so they do not know when new product might be available.

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    1. I couldn’t get through on the phone and finally left my name and number for a call back. It is odd to demand proof of the replacement, they sold a more expensive product we can’t use now after all…

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  4. Hi, I received an email from Sanofi today with these instructions:

    Return & Reimbursement Process

    Sanofi US will reimburse patients for the out-of-pocket costs (the price you pay at the pharmacy) incurred to replace their unexpired Auvi-Q devices with a replacement epinephrine auto-injector. In addition, if you purchased Auvi-Q devices at a cost that exceeds the cost of your replacement devices, Sanofi will compensate you for the difference, with proof of original and replacement product purchases. Please return ALL Auvi-Q devices.

    Below are the steps you should follow.

    1.
    Contact Your Healthcare Provider to Get a Prescription for a Replacement Device
    You should immediately contact your healthcare provider for a prescription for an alternate epinephrine auto-injector. Keep the pharmacy receipt that details your out-of-pocket expense (the price you paid the pharmacy) for your new device.

    2.
    Call to Arrange for Auvi-Q Return
    Call 877‑319‑8963 or 866‑726‑6340 ​8 a.m. to 8 p.m. ET, seven days a week to arrange for a return packet to be shipped to you (please check http://www.Auvi-Q.com for updated hours). In approximately seven to ten days you will receive a prepaid mailing envelope, which will include a return form and a prepaid mailing label.

    3.
    Return All of Your Auvi-Q Devices
    Please return ALL Auvi-Q devices. Sanofi US will reimburse patients for the out-of-pocket costs (the price you pay at the pharmacy) incurred to replace their unexpired Auvi-Q devices with a replacement epinephrine auto-injector. In addition, if you purchased Auvi-Q devices at a cost that exceeds the cost of your replacement devices, Sanofi will compensate you for the difference, with proof of original and replacement product purchases.

    Attach the prepaid return mailing label to the outside of the return envelope and put the package in the mail with your Auvi-Q devices and proofs of purchase. The prepaid shipping label is pre-addressed to the Sanofi US recall processor.

    Once your devices have been placed in the mail, please allow 30 days for processing and to receive your check.

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