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(Yahoo)   Gilead recalls vials of its Remdesivir due to glass contamination. You know. Remdesivir. The covid drug given by intravenous (IV) infusion   (finance.yahoo.com) divider line
    More: Fail, The Washington Post, Oseltamivir, Clinical trial, Food and Drug Administration, Hospital, Gilead Sciences, Health care, Donald Trump  
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2250 clicks; posted to Main » on 05 Dec 2021 at 5:05 AM (6 weeks ago)   |   Favorite    |   share:  Share on Twitter share via Email Share on Facebook



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2021-12-04 11:31:28 PM  
CEO, Irwin Mainway, unavailable for comment?
 
2021-12-05 5:11:03 AM  
Fark user imageView Full Size

Soon turned out...
 
2021-12-05 5:30:35 AM  
Fark medical community, is this "oh my God, this will ruin the IV dispensers"? Or "OH MY GOD!! If one piece of glass gets into a patient's heart!!1!"
 
2021-12-05 5:35:49 AM  

jokerscrowbar: [Fark user image image 425x729]
Soon turned out...


I had a toe of glass
 
2021-12-05 5:36:48 AM  

jokerscrowbar: [Fark user image image 425x729]
Soon turned out...


Nice camel toe. Would be a shame if something happened to it.
 
2021-12-05 5:37:52 AM  

Resident Muslim: Fark medical community, is this "oh my God, this will ruin the IV dispensers"? Or "OH MY GOD!! If one piece of glass gets into a patient's heart!!1!"


USP<790> wants to know what is going on in this thread.
 
2021-12-05 5:41:40 AM  

Resident Muslim: Fark medical community, is this "oh my God, this will ruin the IV dispensers"? Or "OH MY GOD!! If one piece of glass gets into a patient's heart!!1!"


Emboli to the brain more like it. Our pulmonary and cardiovascular patient would suddenly become a neuro pt with a CVA.
 
2021-12-05 5:59:57 AM  
Yeah, They don't issue a recall when one vial is shedding.  There's a statistical sh*tload of liability out there.  You're still probably safe.  Maybe ask if the pharmacy uses an in-line filter when they reconstitute it - You know, while you're in a hospital struggling with your declining lungs.

/Don't forget to itemize your menu before they use anything and bill you for it!
 
2021-12-05 6:00:04 AM  
Instant fix?
Fark user imageView Full Size
 
2021-12-05 6:15:26 AM  
we can only hope healing from the glass may be acheived with a sort of balm
 
2021-12-05 6:36:26 AM  
But those masks and vaccines are the real danger.
 
2021-12-05 6:44:45 AM  

jokerscrowbar: [Fark user image 425x729]
Soon turned out...


No amount of staring was answering the question of if she was wearing pants or not, so I had to google it. Pants, everyone - she was wearing purple tights. And not just wearing either <cigar and eyebrow waggle>.
 
2021-12-05 7:11:03 AM  
Oh holy fark.
 
2021-12-05 7:20:51 AM  

Wobambo: jokerscrowbar: [Fark user image 425x729]
Soon turned out...

No amount of staring was answering the question of if she was wearing pants or not, so I had to google it. Pants, everyone - she was wearing purple tights. And not just wearing either <cigar and eyebrow waggle>.


Aptly, her eyebrows are a clue to what colour carpet you'd find at the camel lodge.
 
2021-12-05 7:24:24 AM  
So it's like Goldschlager, where the little gold flakes create tiny cuts in your esophagus which gets the alcohol into your bloodstream faster which gets you more drunker? Do I need to pay extra for the glass enhanced super medicine?
 
2021-12-05 7:33:20 AM  

Resident Muslim: Fark medical community, is this "oh my God, this will ruin the IV dispensers"? Or "OH MY GOD!! If one piece of glass gets into a patient's heart!!1!"


It actually looks like this is a medication, unlike ampule medications like TXA, certain pain medicines and Epinephrine, which can't be drawn up with a filter needle. (I use these examples because they're the ampule medications Im most familar with)

So glass in the solution could actually be a big problem.

That said, that's why the line "visually inspect the solution once reconstituted and discard if material is noted" is in the preparation instructions.
 
2021-12-05 7:34:33 AM  

Nana's Vibrator: Maybe ask if the pharmacy uses an in-line filter when they reconstitute it


I dont think you can actually use an in-line filter on this product since it's a larger biologic, according to the pharmacy preparation manuals I've been able to find.

Of course, IANAE in this, since we don't give it in our environment.
 
2021-12-05 7:35:08 AM  
That's it.  I'm going back to bleach.
 
2021-12-05 7:48:09 AM  

Northern: Resident Muslim: Fark medical community, is this "oh my God, this will ruin the IV dispensers"? Or "OH MY GOD!! If one piece of glass gets into a patient's heart!!1!"

USP<790> wants to know what is going on in this thread.


Fark user imageView Full Size


/I am convinced world peace cannot happen until the USP, JP, and EP are fully harmonized
 
2021-12-05 7:58:45 AM  
Pray for Fast Five Freddy
 
2021-12-05 7:59:52 AM  
Resident Muslim:

Fark the IV pumps, worst case scenario is that the shard makes it to pulmonary artery and causes a lung bleed, which is not a simple thing to fix. Blood hits the lungs first before either the hearts vasculature or brain, so it'd take the shard.
 
2021-12-05 8:18:57 AM  
Gilead will undoubtedly punish the Handmaidens who are responsible for this error.
 
2021-12-05 8:20:02 AM  

tommyl66: So it's like Goldschlager, where the little gold flakes create tiny cuts in your esophagus which gets the alcohol into your bloodstream faster which gets you more drunker? Do I need to pay extra for the glass enhanced super medicine?


No way!
That's a thing?
Eating gold flakes is apparently a thing in Indian/Sub-continent culture.

/I abhor it on the principle of the thing
 
2021-12-05 8:25:43 AM  

Resident Muslim: tommyl66: So it's like Goldschlager, where the little gold flakes create tiny cuts in your esophagus which gets the alcohol into your bloodstream faster which gets you more drunker? Do I need to pay extra for the glass enhanced super medicine?

No way!
That's a thing?
Eating gold flakes is apparently a thing in Indian/Sub-continent culture.

/I abhor it on the principle of the thing


Yeah, it's sick. Back in high school my best friend's sister's boyfriend's brother's girlfriend heard from this guy who knows this kid who's going with the girl who saw a senior do one shot of Goldschlager and pass out at 31 Flavors one night. I guess it's pretty serious.
 
2021-12-05 8:28:48 AM  
Marketing is now re thinking their choice of spokesperson

Fark user imageView Full Size
 
2021-12-05 8:31:21 AM  
Also, this drug causes major kidney problems.  Wait, not on approved Q&A lists.
Fark user imageView Full Size
 
2021-12-05 8:58:48 AM  
Big Pharma.
Hallelujah.
Every man.
Every man for himself.
 
2021-12-05 9:01:13 AM  

jokerscrowbar: [Fark user image image 425x729]
Soon turned out...


Uh, I think we've got our new 'what color is this dress' argument.

Is she actually wearing pants or not?
 
2021-12-05 9:03:04 AM  
N/m, seems the mystery has been uncovered
 
2021-12-05 9:25:31 AM  
Still no cure for micro-chip contamination.
 
2021-12-05 9:40:28 AM  
It's actually quite common, you just don't see all the recall notices.

Relax, when they are drawing this shiat up, they usually keep a pretty close eye on it.

Just hope they aren't drunk or hungover and you'll be fine. 😊
 
2021-12-05 9:52:36 AM  
Has anybody read the insert or application? Is an in-line POU filter recommended? If so, there's a very low pt risk, and the issue is that they aren't meeting the quality standards as filed with the FDA.
 
2021-12-05 9:54:56 AM  

PhoenixFarker: Has anybody read the insert or application? Is an in-line POU filter recommended? If so, there's a very low pt risk, and the issue is that they aren't meeting the quality standards as filed with the FDA.


I linked the approval document above. It's given infusion with a filter, but the shots are not given with a filter needle.
 
2021-12-05 10:17:31 AM  
The suspected lots were made at the factory annex, a building disguised as a Four Seasons Landscaping business.  The landscapers had dirt under their fingernails but no one caught that until the vials shipped.

Fark user imageView Full Size
 
2021-12-05 10:25:21 AM  
The glass is the active ingredient.
 
2021-12-05 10:35:17 AM  
Now, if they could only recall a few congressmen really hoping for a theocracy....
 
2021-12-05 10:38:36 AM  

hardinparamedic: PhoenixFarker: Has anybody read the insert or application? Is an in-line POU filter recommended? If so, there's a very low pt risk, and the issue is that they aren't meeting the quality standards as filed with the FDA.

I linked the approval document above. It's given infusion with a filter, but the shots are not given with a filter needle.


From what I read in the link and elsewhere this product is only administered via IV infusion. The syringes mentioned in the linked document were used to prep the product rather than administer it, e.g., reconstituting freeze-dried product or transferring reconstituted product into the infusion bag. 

I only help make stuff like this, so any healthcare professionals with relevant experience prepping, prescribing, or administering remdesivir are welcome and encouraged to chime in and correct any misunderstandings.

That said, there looks to be little pt risk if POU filters are used. Based on what I knew at this moment, If I were running the investigation, I'd assess pt risk as low but recommend a recall as it doesn't meet a critical quality attribute.

I'm sure the root cause analysis is being, or has been, vigorously conducted. I know some Gilead quality folks, they are pretty good and wouldn't whitewash something like this.
 
2021-12-05 11:12:35 AM  

Resident Muslim: Fark medical community, is this "oh my God, this will ruin the IV dispensers"? Or "OH MY GOD!! If one piece of glass gets into a patient's heart!!1!"


It will not damage IV Infusion pumps.  No part of the pump is actually ever in contact with the infusion or dilutant.  All major pump brands (ICU Medical, CareFusion, B.Braun, Baxter) sell dedicated disposable sets that snap into the pump (well,Baxter is a peristaltic pump that actually doesn't use a set, it just directly massages the tubing, but this is a bad idea and will cause the tube to break if the pump is not moved frequently.  Nurses do not like Baxter pumps or Baxter tubing).

This could damage an IV set, catheter, or tubing, but all that stuff is disposable.
 
2021-12-05 11:23:36 AM  
Am I the only one interested in "How did glass shards get in an IV drug?"
 
2021-12-05 11:27:07 AM  

NewportBarGuy: It's actually quite common, you just don't see all the recall notices.

Relax, when they are drawing this shiat up, they usually keep a pretty close eye on it.

Just hope they aren't drunk or hungover and you'll be fine. 😊


What is the major issue is that when a contaminated vial is found, the whole production lot has to be pulled.

Most companies will keep a bit of reserve product to protect against critical understocking of proprietary vials.  If that reserve happens to be from the same lot(s) as the contaminated product, then you have a major issue where you are having daily calls with product management, prioritizing delivery of the scant remaining product to keep key customers from not discarding your pain management pump that requires no longer available proprietary vials.

Now they are careful to make sure the reserves are heterogeneous.
 
2021-12-05 12:33:48 PM  

rainbowbutter: we can only hope healing from the glass may be achieved with a sort of balm


Is there no balm in Gilead?
 
2021-12-05 12:43:56 PM  
Another reason to get vaccinated.
 
2021-12-05 12:57:29 PM  

mehhhhhh: Instant fix?[Fark user image 425x239]


That'll never work, terrible idea.  Here, lemme get rid of it for you
 
2021-12-05 1:18:39 PM  

jokerscrowbar: [Fark user image 425x729]
Soon turned out...


that's a camel toe of legends right there
 
2021-12-05 1:41:49 PM  

the_rhino: jokerscrowbar: [Fark user image 425x729]
Soon turned out...

that's a camel toe of legends right there


oh ffs it's a seam in her hose.  i mean nylons.
i mean vagina.

Tillmaster:Is there no balm in Gilead?

what with the shipping strikes, it has to route all the way from the night's Plutonian shore- takes a freakin week!  :)
 
2021-12-05 1:49:31 PM  
I thought the headline was referring to Texas.
 
2021-12-05 2:20:51 PM  

hardinparamedic: Nana's Vibrator: Maybe ask if the pharmacy uses an in-line filter when they reconstitute it

I dont think you can actually use an in-line filter on this product since it's a larger biologic, according to the pharmacy preparation manuals I've been able to find.

Of course, IANAE in this, since we don't give it in our environment.


At our place they're taught to look for discoloration or particulates, but we don't use filters on it that I'm aware of. 100 mg doses are only used with mini-bags. Anything above or below is mixed into a larger bag or, for pediatrics, in a syringe.
 
2021-12-05 2:29:34 PM  

nyclon: I thought the headline was referring to Texas. up to


Same, thought they were up to more state-led interference in covid statistics, or getting their nose in more people's medical care.
 
2021-12-05 6:06:37 PM  
For reference, the San Diego police department had roughly 1,800 sworn officers on the street as of September 2020

So this would fit with nationwide patterns in vaccine refusals, less than 10% per organization.
 
2021-12-05 6:07:03 PM  
Oops wrong thread
 
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