EpiPen Serious Manufacturing Violations

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spacecanada:
Just go ahead now and swallow some hot sauce; it might help make this go down easier. :rant:

http://www.marketwatch.com/story/fda-warns-of-serious-manufacturing-violations-in-letter-to-epipen-manufacturing-facility-2017-09-07-141034838

Now I'm really wishing Allerject would return. I know Canadian EpiPens are made by another company (Pfizer), but I have no doubt they get their parts from similar places, if not the exact same source.

A good reminder to always carry two - and from two different lot numbers if possible.

rebekahc:
:rant: :rant: :rant: As if I needed another reason to be disgusted with Mylan!

--- Quote from: spacecanada on September 07, 2017, 03:30:37 PM ---Just go ahead now and swallow some hot sauce; it might help make this go down easier. :rant:

http://www.marketwatch.com/story/fda-warns-of-serious-manufacturing-violations-in-letter-to-epipen-manufacturing-facility-2017-09-07-141034838

Now I'm really wishing Allerject would return. I know Canadian EpiPens are made by another company (Pfizer), but I have no doubt they get their parts from similar places, if not the exact same source.

A good reminder to always carry two - and from two different lot numbers if possible.

--- End quote ---

Actually, I think they're the same probably even in Canada. :-/ It may be that Pfizer gets to keep their name on the box there.

http://www.biospace.com/News/what-you-dont-know-pfizers-connection-to-mylan-and/430408

From the above link:

--- Quote ---Although Mylan manufactures and sells the actual EpiPen device, Pfizer manufactures the drug the device administers. And although the financial deal between the two companies isn’t completely clear, Pfizer has shown increased revenues related to EpiPens for the last few years.
--- End quote ---

And from the MarketWatch link:

--- Quote ---The Food and Drug Administration described “significant violations of current good manufacturing practice” in a warning letter to a Pfizer Inc. unit that manufactures Mylan NV’s EpiPen allergic reaction treatment.
--- End quote ---

GoingNuts:
I just came on tonpost this. Livid doesn't even begin to describe what I feel right now. :rant:

spacecanada:
I'm just beyond words right now. I figured it was all the same somehow: Mylan and Pfizer. :rant:

Copying what I wrote in my local allergy group:

Allerject had similarly reported (though never publicly confirmed) dosing defects and recalled every single unit in North America, completely re-engineered their manufacturing process, and came back to market with a more reliable device (in America only). But, if EpiPen did that, we'd have nothing but phials and syringes like AnaKits before - not a situation anyone wants to be in. I'd rather have two devices with a 99% efficiency rate than a phial and syringe.

I just want to cry. Seriously. Like I need more anxiety over my allergies right now. Allerject needs to come back to Canada. Or we need a miracle cure. Where can I get one of those? :'(