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Title: EPIPEN RECALL - 3/17
Post by: GoingNuts on March 20, 2017, 07:23:55 PM
http://mobile.abc.net.au/news/2017-03-20/epipens-recalled-over-failure-to-activate/8371014
Title: Re: EPIPEN RECALL - 3/17
Post by: my3guys on March 20, 2017, 08:38:50 PM
Holy bananas.
Title: Re: EPIPEN RECALL - 3/17
Post by: BensMom on March 21, 2017, 07:38:06 AM
Geez! DS's expire this month, so his are apparently ok. Of course, we won't get the new auvis until next month I guess because they're behind.  :disappointed:
Title: Re: EPIPEN RECALL - 3/17
Post by: spacecanada on March 21, 2017, 10:49:25 AM
From various sources, it appears the recall is only affecting Australia and Denmark.
Title: Re: EPIPEN RECALL - 3/17
Post by: GoingNuts on March 31, 2017, 05:00:50 PM
Recall Expanded:
http://newsroom.mylan.com/2017-03-31-Mylan-Provides-Update-on-Meridian-Medical-Technologies-a-Pfizer-Company-Expanded-Voluntary-Worldwide-Recall-of-EpiPen-R-Auto-Injector
Title: Re: EPIPEN RECALL - 3/17
Post by: hezzier on March 31, 2017, 05:17:03 PM
We have one set that are on the list.  Will have to call DS's school to find out what the lot number is for that set.
Title: Re: EPIPEN RECALL - 3/17
Post by: nyguy on March 31, 2017, 05:59:31 PM
Mine are dated Jan 18 so not affected. Also have the Auvi-Q units.
Title: Re: EPIPEN RECALL - 3/17
Post by: YouKnowWho on March 31, 2017, 06:11:15 PM
The set DS1 carries is recalled  :rant:
Title: Re: EPIPEN RECALL - 3/17
Post by: candyguru on March 31, 2017, 09:39:24 PM
HERTFORDSHIRE, England and PITTSBURGH, March 31, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that Meridian Medical Technologies, a Pfizer company and Mylan's manufacturing partner for EpiPen® Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA).

This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Both reports are related to the single lot that was previously recalled. The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.

The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016. The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America.

The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.

U.S. Impacted Lots:
Product/Dosage
NDC Number
Lot Number
Expiration Date
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg
49502-501-02
5GN767
April 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg
49502-501-02
5GN773
April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
49502-500-02
5GM631
April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
49502-500-02
5GM640
May 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg
49502-501-02
6GN215
September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
49502-500-02
6GM082
September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
49502-500-02
6GM072
September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
49502-500-02
6GM081
September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
49502-500-02
6GM088
October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
49502-500-02
6GM199
October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
49502-500-02
6GM091
October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
49502-500-02
6GM198
October 2017
EpiPen 2-pak® Auto-Injectors, 0.3 mg
49502-500-02
6GM087
October 2017

Mylan is committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall. Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions. We are asking patients to keep their existing product until their replacement product can be secured.
Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability. The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector.
It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device.
To return your product please contact Stericycle at 877-650-3494. If you have any additional questions regarding this recall, please contact Mylan Customer Relations at 800-796-9526 or customer.service@mylan.com.
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.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or 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 voluntary recall is being conducted with the knowledge of FDA.
Epinephrine is the first-line treatment for a life-threatening allergic reaction (anaphylaxis) and access to this product is critical in the event of an emergency. Delays in epinephrine administration have been associated with negative health consequences.
More information about the risks and benefits of EpiPen® Auto-Injector can be found at EpiPen.com.
Title: Re: EPIPEN RECALL - 3/17
Post by: spacecanada on March 31, 2017, 10:58:21 PM
The recall has made its way to Canada now too:

http://www.pfizer.ca/node/7651

KIRKLAND – March 31, 2017 – Pfizer Canada Inc., the Canadian distributor of EpiPen® (epinephrine) Auto-Injector, today announced a voluntary recall in consultation with Health Canada of one lot of EpiPen 0.3 mg (epinephrine) and one lot of EpiPen Jr 0.15 mg (epinephrine) Auto-Injectors distributed in Canada.

In Canada, the recall impacts one lot (5GU763) of the 0.3 mg strength of EpiPen Auto-Injector expiring in May 2017 and one lot (5GR765) of the 0.15 mg strength of EpiPen Jr Auto-Injector expiring in March 2017.
Title: Re: EPIPEN RECALL - 3/17
Post by: Penny on April 01, 2017, 02:07:17 AM
The recall also applies to New Zealand.
Title: Re: EPIPEN RECALL - 3/17
Post by: BensMom on April 01, 2017, 07:05:36 AM
DS's expired yesterday I guess--March 2017. His auvis are due to arrive next Thursday here and then it'll be another week or two before I get them to him. I told him expired epis are fine for another few months (and possibly longer) so weeks won't matter, but I may take them to him sooner if he's nervous about it.
Title: Re: EPIPEN RECALL - 3/17
Post by: my3guys on April 01, 2017, 09:41:05 AM
We have all the months in the house that aren't recalled. Yet.
Title: Re: EPIPEN RECALL - 3/17
Post by: lakeswimr on April 01, 2017, 05:58:27 PM
Check the NDC #s near the bar code.  I thought ours were recalled but they were not.  one digit was off in the NDC.  The lot and expiration both matched but without all three matching it isn't part of the recall.

Title: Re: EPIPEN RECALL - 3/17
Post by: hezzier on April 02, 2017, 07:49:02 AM
Ok, I went back checked the NDC# and ours is not on the list.  Not to be pessimistic, but how long until it is on the list?
Title: Re: EPIPEN RECALL - 3/17
Post by: PurpleCat on April 02, 2017, 09:03:22 AM
Not only do we have recalled epi pens here, but I am pretty sure the ones at school are part of it too based on date of purchase.   :tongue: :tongue: :tongue:

They are the ones we are carrying right now that expire in September.

Need to go to CVS - UGH!
Title: Re: EPIPEN RECALL - 3/17
Post by: ajasfolks2 on April 02, 2017, 10:25:16 AM
However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.


OK, so I don't really trust Mylan at all at this point and am even wondering if the "expanded recall" is really just bs action to try to make Mylan APPEAR more concerned with consumer safety that Mylan really is?  And perhaps those additional recalls are just to make them look good.

Just sayin'.

We have ZERO way of knowing and will never know.
Title: Re: EPIPEN RECALL - 3/17
Post by: ajasfolks2 on April 02, 2017, 10:25:53 AM
Meanwhile, Mylan tries to go from ZERO-to-HERO in minds of consumers and general public.

Title: Re: EPIPEN RECALL - 3/17
Post by: gvmom on April 02, 2017, 06:23:19 PM
Mylan could be trying to pump up it's image.... but..... right now we have Epi-pen brand auto injectors.  To replace them means that we will be replacing them not with Mylan epipens though.  Our insurance no longer covers them, or their generics. 

So, how much business are they going to lose if you combined people getting auvi-q and those of us who will be bumped over to the CVS auto-injectors?

I guess I don't necessarily know if it makes sense for their bottom line to widen a recall if it isn't absolutely necessary because in the one year-ish time span Epipens last, insurance companies are dumping them and two other options are out and theoretically covered.

How many people will really be replacing their recalled Mylan Epipens with Mylan Epipens? 

Title: Re: EPIPEN RECALL - 3/17
Post by: ajasfolks2 on April 02, 2017, 09:23:56 PM
I've not checked ours to see if recalled -- will have to call schools tomorrow too.

And I have no idea what our insurance will even allow now (Tricare Standard) . . . . CVS not part of Tricare anymore.

But this sure brings home the plan we used to have of having multiple batches and serial numbers and splitting them up between kids.

~ ~ ~

Maybe while Mylan was raking in all that $$$$$$$$$$$$$$$ they should have been looking harder at key components that could fail or had failed in past and sourcing from different parts providers?  Weren't they supposedly plowing this $$$$$$$$$$$$$$$$$$$4 into research and development??

No, you say?

Or just plowing it all into a CEO's pocket so she could go buy more haute couture shoes?

Mais oui, nous aurions du savior.

Title: Re: EPIPEN RECALL - 3/17
Post by: MaryM on April 03, 2017, 08:00:46 AM
Just got a call from the nurse at DS's school.  His Epi-Pens have been recalled.  Luckily he has a new set that are fine that he self carries and the school has about 6 stock pens that are not recalled.  They gave the box to DS to bring home but she is going to email me the lot number so I can get started on replacements fro Mylan.  Still waiting to hear if DD's Epi-Pens are ok.  I just refilled a script for and got the Mylan generics.  I am actually waiting for my second box to arrive because they pharmacy only had one.  They had originally given me the other generic one but I feel more comfortable with the Mylan one. since its the exact same thing as the name brand Epi.
Title: Re: EPIPEN RECALL - 3/17
Post by: PurpleCat on April 03, 2017, 09:05:26 AM
Been on hold so far for almost an hour!  This is very painful!  Seriously, they really need a better system but these drug companies could care less about us...the customers that help pay their salaries!

School nurse said the office stock epi's are not part of the recall and she will use one of those if DD needs one at school.

and now....back to "continue to hold".....with really bad music!
Title: Re: EPIPEN RECALL - 3/17
Post by: PurpleCat on April 03, 2017, 10:28:16 AM
I was on hold for 1 hour 49 minutes!  How did I get off hold.  Took the phone to the bathroom of course!  LOL!  Figures.

Anyway, the phone call took less than 5 minutes...they just take your info, will mail slips to cover replacements.

I have wasted my whole morning!
Title: Re: EPIPEN RECALL - 3/17
Post by: MaryM on April 03, 2017, 12:11:08 PM
So this what I have to look forward to tomorrow, eh?

Allergist called in a new script for DS since he had no more refills.  Nurse at our school has stock Epi if DS needed plus he self carries.  What a pain.
Title: Re: EPIPEN RECALL - 3/17
Post by: hezzier on April 03, 2017, 01:27:32 PM
At least you have heard back from your school, I'm still waiting and I called at 8 am.
Title: Re: EPIPEN RECALL - 3/17
Post by: my3guys on April 03, 2017, 01:49:49 PM
Yep, school epis are part of the recall. Now to get my hands on replacements.
Title: Re: EPIPEN RECALL - 3/17
Post by: PurpleCat on April 03, 2017, 02:33:33 PM
We have a wonderful allergist.  I messaged her while I was on hold and vented about the process plus asked her about getting us Auvi Q and had some going to college questions.

Her nurse called me this afternoon.  They are concerned that we do not have any epi pens not in the recall so they are getting me a twin pack for DD immediately.  Tomorrow I will go there and pick that up, plus a new written prescription that has not gone through insurance for the replacements so I have that with the form I get from Mylan (the replacement can not go through insurance).  They will also have the form for Auvi Q ready for me to add information and give a copy of my insurance card that they will submit.  Then she walked me through how they will set up allergy shots for DD in college.  The rest of my questions can be covered during our next food challenge in April.

Such a relief to have help!
Title: Re: EPIPEN RECALL - 3/17
Post by: MaryM on April 04, 2017, 09:03:52 AM
I am on hold about our recalled Epis.  They say the wait time is 42 minutes....good thing I have a lot to do around the house today.
Title: Re: EPIPEN RECALL - 3/17
Post by: my3guys on April 04, 2017, 12:39:54 PM
Oh Mary you're ahead of me! Wait time is 90 minutes!
Title: Re: EPIPEN RECALL - 3/17
Post by: MaryM on April 04, 2017, 01:05:34 PM
Well my phone went bonkers and died.  I didn't call back.  I will try tomorrow early.
Title: Re: EPIPEN RECALL - 3/17
Post by: hezzier on April 04, 2017, 01:23:18 PM
Well, I just had an interesting call.  I drive to a military installation to get our epi pens and their pharmacy just called looking for DS.  I said I was his mother and that she needed to speak with him...my response was that he's 12.  So then she proceeds to tell me about the epi pen recall and wants to go over all the lot numbers.  I give her the first ones and she says that it's on the list and I said but the NDC # doesn't match and she said they were only going by lot numbers.  So I was instructed to bring them to the pharmacy and they will replace them.  I need to go get DD's epi pen prescription filled anyway so I'm glad I hadn't already done that.
Title: Re: EPIPEN RECALL - 3/17
Post by: YouKnowWho on April 04, 2017, 03:03:54 PM
Our store called us to let me know that my son's was recalled.  But I have to go through the fun of calling the company handling the the recall.  I will do that early next week in hopes wait times drop.
Title: Re: EPIPEN RECALL - 3/17
Post by: MaryM on April 05, 2017, 08:06:00 AM
I am on hold again.  The wait time was 23 minutes when I called.  I am down to 14.  Fingers crossed that my phone does not go bonkers again.
Title: Re: EPIPEN RECALL - 3/17
Post by: hezzier on April 05, 2017, 03:20:16 PM
Pharmacy replaced recalled epi pens today. 
Title: Re: EPIPEN RECALL - 3/17
Post by: spacecanada on April 05, 2017, 08:52:18 PM
My pharmacy called me to check my lot numbers, none of which were part of the recall.  Here, you just bring the recalled EpiPens to the pharmacy and they give you a new one.  They deal with all the exchange stuff right there. 
Title: Re: EPIPEN RECALL - 3/17
Post by: PurpleCat on April 18, 2017, 11:26:15 AM
Still not replaced....still working on it.  Our CVS pharmacist is working on it...it is not CVS.  At least not mine.  They can't get the replacement epi pens.

Also, the company has been so slow sending documentation and emailing info that yesterday, the woman Mylan connected me with gave me all the numbers over the phone to give to the pharmacist.  I could care less at this point when they send me the box for returns...I want new epi pens.

Armed with both RX and voucher numbers and a promise of a big direct delivery from Mylan of epi pens, my pharmacist hopes to have Epi's for me on Friday or next Tuesday.

Meanwhile I need my own spinner!  Twiddling my thumbs instead....
Title: Re: EPIPEN RECALL - 3/17
Post by: PurpleCat on April 21, 2017, 10:35:42 AM
CVS pharmacist got us one twin pack last night!  She really went out of her way to be sure we had one to start.  I picked it up when they opened at 8:00.

She is still expecting her big shipment to come later today or next Tuesday.  She will finish the order then.

So nice of her!
Title: Re: EPIPEN RECALL - 3/17
Post by: PurpleCat on May 02, 2017, 12:34:50 PM
CVS got me the other two twin packs yesterday!  Finally!  Went to the school this morning to exchange for recalled ones.  Feeling protected again.
Title: Re: EPIPEN RECALL - 3/17
Post by: my3guys on September 07, 2017, 06:16:58 PM
According to an article on MSNBC, more epipen recalls are coming!!! Claims are that all complaints haven't been investigated and defective product was left on shelves. I can't link article right now but I will later.
Title: Re: EPIPEN RECALL - 3/17
Post by: rebekahc on September 07, 2017, 07:21:44 PM
Here's a link to an ongoing discussion. At some point we may want to merge these threads...

EpiPen Serious Manufacturing Violations
Title: Re: EPIPEN RECALL - 3/17
Post by: my3guys on September 08, 2017, 12:57:42 PM
Thanks for linking.
Title: Re: EPIPEN RECALL - 3/17
Post by: ajasfolks2 on September 20, 2017, 02:27:39 PM
Are there more serial / lot numbers recalled now?  Wanting to be sure son has enuf supposedly ok Epipens for now.

Title: Re: EPIPEN RECALL - 3/17
Post by: nyguy on September 29, 2017, 10:06:16 AM
Are there more serial / lot numbers recalled now?  Wanting to be sure son has enuf supposedly ok Epipens for now.

No new recalls but my faith in Mylan at this point is gone.

Sanofi/Intelliject (Intelliject renamed them selves to Kaleo) had a little over a couple dozen reports of malfunctions (with no fatalities) and they hard stop did a full recall of Auvi-Q, with Sanofi reverting the rights to Kaleo, Kaleo doing a post-mortem and making sweeping manufacturing/testing changes, and bringing it back to market.

Meridian (making the drug) had hundreds of reports of issues including multiple deaths. In certain cases, they confirmed that deformed/malfunctioning specific components were at fault, and then did not look to see if other units in the same lot had the same defective component or issue a recall.

The fact that EpiPen has been around for decades is no comfort because it was redesigned in 2009 and the year of a redesign says nothing about the continuous quality of an autoinjector, failures and manufacturing defects can happen at any time. If they aren't adequately QCing them, randomly auditing lots, and then properly assessing product failures and erring on the side of caution for recalls then I don't have any confidence that newer lots are necessarily properly built.

Since I have commercial insurance and can get Auvi-Q for free, that's where my faith is. If not, I would look to get covered for the generic from Lineage.