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FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr
fda.gov ^ | March 31, 2017 | FDA

Posted on 04/01/2017 6:16:15 AM PDT by Delta 21

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recalldisclaimer icon of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.

While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Mylan at 800-796-9526 or customer.service@mylan.com with any questions.

As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.

At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.

~~~~~~~~~~~~~listed lot #s at the source~~~~~~~~~~~~~~~

The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by:

Completing and submitting the report online at www.fda.gov/medwatch/report.htm, or Downloading and completing the form, then submitting it via fax at 800-FDA-0178.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###


TOPICS: Business/Economy; Crime/Corruption; Government
KEYWORDS: epipen; recall
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The list of lot #s effected is at the source.

Jack the price up 600%, give customers a break with 50% savings! Whats the only way left to make money on this device?

How bout we just make 'em look like the real thing with junk inside? Cha-Ching !!

1 posted on 04/01/2017 6:16:15 AM PDT by Delta 21
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To: Delta 21

Imagine how much they’d cost if you could count on them to work.


2 posted on 04/01/2017 6:45:31 AM PDT by Wolfie
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To: Tilted Irish Kilt

Could be of interest to your ping list.


3 posted on 04/01/2017 7:14:20 AM PDT by Whenifhow (when, if and how will Obama be gone?)
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To: Whenifhow; appalachian_dweller; OldPossum; DuncanWaring; VirginiaMom; CodeToad; goosie; kalee; ...
Prepper List : Ping (Medical appliance issue)

Nationwide voluntary recall of EpiPen and EpiPen Jr.


(from the article):" At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall.
Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.
EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated.
This recall is based upon the EpiPen failing to activate.

Hat Tip to Whenifhow !

4 posted on 04/01/2017 8:03:34 AM PDT by Tilted Irish Kilt (Muslim & Spanish migrants are like Kudzu--> designed to overload the system= Cloward-Piven)
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To: Wolfie

Yeah, something fishy is going on with that company. This much controversy all at once is a brow raiser.

Can’t forget that stupid mother who wouldn’t use a recently expired one on her son so he died.


5 posted on 04/01/2017 8:07:42 AM PDT by bgill (From the CDC site, "We don't know how people are infected with Ebola")
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To: Delta 21

Not content with PRICE GOUGING us, now they’ve moved on to outright KILLING us!

Remember when, ‘She Who Shall not Be Named’ was involved with flu vaccine suppliers one year? Yep. Shortages all around and people DIED due to that beotch’s meddling.

Don’t get sick and don’t get old. That’s my advice. ;)


6 posted on 04/01/2017 9:03:18 AM PDT by Diana in Wisconsin (I don't have 'Hobbies.' I'm developing a robust Post-Apocalyptic skill set!)
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To: bgill

The CEO is a Friend Of Hillary with connections to the Obama FDA and Department of Education.

They lobbied FedGoV (FDA) to require prescribing two at a time. Then lobbied Education to require that all public schools MUST have a certain number of EpiPens. Then lobbied FDA again to suppress or deny licensing for generic competitors. Then, through a series of steps, raised the price to $600.


7 posted on 04/01/2017 9:26:57 AM PDT by DBrow
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To: bgill

“Can’t forget that stupid mother who wouldn’t use a recently expired one on her son so he died.”

I thought that was an EMT. In any case it says in the tiny print on the patient insert that there are no contraindications when it’s life or death.


8 posted on 04/01/2017 9:28:30 AM PDT by DBrow
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To: Delta 21; 3D-JOY; abner; Abundy; AGreatPer; Albion Wilde; AliVeritas; alisasny; ...
For y'all EpiPen users on all my ping lists.

MEGA-PING!

9 posted on 04/01/2017 10:04:20 AM PDT by Tolerance Sucks Rocks (April 2006 Message from Dan: http://www.dansimmons.com/news/message/2006_04.htm)
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To: Tolerance Sucks Rocks

BTTT


10 posted on 04/01/2017 10:50:38 AM PDT by E.G.C.
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To: Delta 21

For later.

L


11 posted on 04/01/2017 10:52:28 AM PDT by Lurker (America burned the witch.)
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To: Delta 21

Would it be too much to expect them to replace FOR FREE the defective ones?


12 posted on 04/01/2017 3:32:03 PM PDT by metmom ( ...fixing our eyes on Jesus, the Author and Perfecter of our faith...)
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To: Delta 21; 2Jedismom; 6amgelsmama; AAABEST; aberaussie; AccountantMom; adopt4Christ; Aggie Mama; ...

To any Epi-Pen users on my ping lists.


13 posted on 04/01/2017 3:39:03 PM PDT by metmom ( ...fixing our eyes on Jesus, the Author and Perfecter of our faith...)
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To: Delta 21

This is why I have a bottle of epi and 2 syringes. I can draw a dose in 15 seconds....


14 posted on 04/01/2017 4:50:01 PM PDT by clee1 (We use 43 muscles to frown, 17 to smile, and 2 to pull a trigger. I'm lazy and I'm tired of smiling.)
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To: Delta 21; alarm rider; Alex1977; at bay; Babsig; BILL_C; bnelson44; ColdOne; DesScorp; G.Love; ...

Ping to all the ping lists I manage:

FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr.


15 posted on 04/01/2017 5:07:49 PM PDT by upchuck (U have not lived today until u have done something for someone who can never repay u ~ John Bunyan)
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To: DBrow

I think it is Joe Manchin’s daughter at Meridian.


16 posted on 04/01/2017 5:40:10 PM PDT by ecomcon
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To: metmom

Thanks. We had not heard.


17 posted on 04/01/2017 6:04:37 PM PDT by refreshed (But we preach Christ crucified... 1 Corinthians 1:23)
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To: ecomcon

She’s the CEO of Mylan.


18 posted on 04/01/2017 6:16:06 PM PDT by Reily
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To: refreshed

I just saw this.

I checked mine and they are all OK.


19 posted on 04/01/2017 6:34:42 PM PDT by metmom ( ...fixing our eyes on Jesus, the Author and Perfecter of our faith...)
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To: Delta 21

Funny. I was majorly courted for a job with them through a contractor just 2 years ago (was down the street from us).


20 posted on 04/01/2017 7:27:16 PM PDT by the OlLine Rebel (Common sense is an uncommon virtue./Federal-run medical care is as good as state-run DMVs.)
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