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Mensch
Picture of kz1000
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You'll wanna take it again 2 hours later...


------------------------------------------------------------------------
"Yidn, shreibt un fershreibt"

"The Nazis entered this war under the rather childish delusion that they were going to bomb everyone else, and nobody was going to bomb them. At Rotterdam, London, Warsaw and half a hundred other places, they put their rather naive theory into operation. They sowed the wind, and now they are going to reap the whirlwind."
-Bomber Harris
 
Posts: 16119 | Location: Ivorydale | Registered: January 21, 2005Reply With QuoteReport This Post
אַרְיֵה
Picture of V-Tail
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quote:
Originally posted by kz1000:
You'll wanna take it again 2 hours later...
Big Grin



הרחפת שלי מלאה בצלופחים
 
Posts: 30546 | Location: Central Florida, Orlando area | Registered: January 03, 2010Reply With QuoteReport This Post
goodheart
Picture of sjtill
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quote:
The raw material for the recalled heparin batches was processed in China from pig's intestines by the American pharmaceutical firm Scientific Protein Laboratories.[3][4][5] The U.S. Food and Drug Administration was quoted as stating that at least 81 deaths were believed to be linked to a raw heparin ingredient imported from the People's Republic of China, and that they had also received 785 reports of serious injuries associated with the drug’s use.[6] According to The New York Times, "problems with heparin reported to the agency include difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that in some cases led to life-threatening shock."[4]

Upon investigation of these adverse events by the FDA, academic institutions, and the involved pharmaceutical companies, the contaminant was identified as an "over-sulfated" derivative of chondroitin sulfate, a closely related substance obtained from mammal or fish cartilage and often used as a treatment for arthritis.[3][7] Since over-sulfated chondroitin is not a naturally occurring molecule, costs a fraction of true heparin starting material, and mimics the in-vitro properties of heparin, the counterfeit was almost certainly intentional as opposed to an accidental lapse in manufacturing.[8] The raw heparin batches were found to have been cut from 2–60% with the counterfeit substance, and motivation for the adulteration was attributed to a combination of cost effectiveness and a shortage of suitable pigs in China.

When the FDA conducted an inspection of Baxter's Chinese Heparin supplier, it found serious deficiencies at the facility which the FDA detailed in a warning letter.[9][10]

This example once again demonstrated the consequences of a company not following basic Good Manufacturing Practices (GMPs). As detailed in the Warning Letter, the company failed to monitor changes in the impurity profile of incoming heparin active raw material, adequately investigate out-of-specification results, document actual processing steps in batch records, validate all critical steps in the process, qualify all suppliers, and use valid methods to test products.

The FDA has stated that it does not have the funds nor bear the responsibility to inspect on a regular basis overseas upstream processors of finished active pharmaceutical ingredients such as heparin. However, according to the internationally harmonized guideline, ICH Q7, API manufacturers are fully responsible for qualifying their suppliers through on-site audits, testing, and regular communications. This ongoing responsibility is essential to ensure supply chain security, drug quality and drug safety, These basic commitments to the pharmaceutical consumer can only be ensured by adherence to Good Manufacturing Practice and Good Distribution Practice


Link


_________________________
“ What all the wise men promised has not happened, and what all the damned fools said would happen has come to pass.”— Lord Melbourne
 
Posts: 18018 | Location: One hop from Paradise | Registered: July 27, 2004Reply With QuoteReport This Post
Little ray
of sunshine
Picture of jhe888
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The FDA tries, but I'm not sure how effective they can be. I'd avoid it.




The fish is mute, expressionless. The fish doesn't think because the fish knows everything.
 
Posts: 53118 | Location: Texas | Registered: February 10, 2004Reply With QuoteReport This Post
Member
Picture of EasyFire
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Nope...nope...nope. Why is this even a consideration?


EasyFire [AT] zianet.com
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Posts: 1441 | Location: Denver Area Colorado | Registered: December 14, 2008Reply With QuoteReport This Post
Not really from Vienna
Picture of arfmel
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Because it’s cheaper for the insurance company, probably.
 
Posts: 26852 | Location: Jerkwater, Texas | Registered: January 30, 2007Reply With QuoteReport This Post
Thank you
Very little
Picture of HRK
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take it back, tell them "no msg"



 
Posts: 23244 | Location: Florida | Registered: November 07, 2008Reply With QuoteReport This Post
Chip away the stone
Picture of rusbro
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quote:
Originally posted by Oz_Shadow:
I do not trust China.


It's got tiger tusks and cow testicles in it. Very potent stuff.
 
Posts: 11597 | Registered: August 22, 2008Reply With QuoteReport This Post
Member
Picture of wrightd
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quote:
Originally posted by rusbro:
quote:
Originally posted by Oz_Shadow:
I do not trust China.


It's got tiger tusks and cow testicles in it. Very potent stuff.

... and if you take it, you can grow your own !

I personally don't eat or drink anything from china. period. seriously.




Lover of the US Constitution
Wile E. Coyote School of DIY Disaster
 
Posts: 8637 | Location: Nowhere the constitution is not honored | Registered: February 01, 2008Reply With QuoteReport This Post
Go Vols!
Picture of Oz_Shadow
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Original post updated - FDA recall of the one I got!
 
Posts: 17871 | Location: SE Michigan | Registered: February 10, 2007Reply With QuoteReport This Post
Shaman
Picture of ScreamingCockatoo
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quote:
Baxter's Chinese Heparin

This investigation goes back to 2008.
How in the fuck is this company still in business?
They should have been sued into insolvency and it's officers executed.





He who fights with monsters might take care lest he thereby become a monster.
 
Posts: 39716 | Location: Atop the cockatoo tree | Registered: July 27, 2002Reply With QuoteReport This Post
member
Picture of henryaz
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quote:
Originally posted by 12131:
Chinese med's side effect: impotence.

You're supposed to order some powdered rhinoceros horn with the meds.
 
 
Posts: 10778 | Location: South Congress AZ | Registered: May 27, 2006Reply With QuoteReport This Post
Conveniently located directly
above the center of the Earth
Picture of signewt
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"I don't know why we would trust our meds to Chinese production."

this remains an open question in many other critical products as well

'simple greed' does not seem to be an adequate response

Years ago (around 2010) my anxieties were tweaked when reading story of outsourced aircraft turbine blades.


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Posts: 9849 | Location: sunny Orygun | Registered: September 27, 2009Reply With QuoteReport This Post
Member
Picture of Censored
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It's not just the meds, but components too. If you are into GMP you better know your stuff.

https://en.wikipedia.org/wiki/Toxic_cough_syrup

There were poisonings in Panama, China, Haiti, Bangladesh, Argentina, Nigeria, and India (twice) between 1992 and 2007, due to contaminated cough syrup and other medications that incorporated inexpensive diethylene glycol instead of the intended glycerin. In May 2007, 365 deaths were reported in Panama.[2]

In Panama, the imported diethylene glycol came from a Chinese manufacturer, sold under the unfortunate name TD glycerine, which means 'glycerine substitute'. A Spanish middleman filling the customs declaration changed the name to glycerine.

The China Food and Drug Administration did not regard the toxic cough syrup scandal as being China's fault. The Chinese manufacturer exported the diethylene glycol under the name TD glycerine, but the Spanish middleman Aduanas Javier de Gracia changed the name to glycerine when he filled the customs declaration in Panama
 
Posts: 2223 | Location: United States | Registered: February 13, 2006Reply With QuoteReport This Post
Member
posted Hide Post
Or to India!?!?

Had the Indian director of the diagnostic laboratory refuse his medication fills if the source was India. He said QC did not exist there. Pure greed may be the simplest and most correct explanation for the whole fiasco.


quote:
Originally posted by signewt:
"I don't know why we would trust our meds to Chinese production."

this remains an open question in many other critical products as well

'simple greed' does not seem to be an adequate response

Years ago (around 2010) my anxieties were tweaked when reading story of outsourced aircraft turbine blades.


GW.
 
Posts: 642 | Location: Auburn, AL | Registered: August 24, 2012Reply With QuoteReport This Post
Leave the gun.
Take the cannoli.
posted Hide Post
quote:
Originally posted by Jimbo54:
Oh hell no!. BP medication is cheap, cheap. Why would anyone buy it from China.


Because you don’t know. Do you ask your pharmacist the country of origin of every refill you get? The doctor writes an Rx and the pharmacist fills it.

I went to RiteAide yesterday with my empty Valsartan bottle and the guy just shook his head. Said he’ll call my doc for a replacement and he did confirm it was a Chinese problem.

Fuck the FDA, too! The FDA release does not mention Chinese production.
 
Posts: 6634 | Location: New England | Registered: January 06, 2003Reply With QuoteReport This Post
Member
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My Wife's Doctor made a point to call her and told her to stop taking the meds and called in a different prescription.

when filled by the pharmacy, you really don't know what generic is being provided. but the insurance co probably does.

this was a new GP for her, originally prescribed by another GP. luckily one cared enough to call.
 
Posts: 476 | Location: Greensboro, NC | Registered: November 26, 2009Reply With QuoteReport This Post
Go Vols!
Picture of Oz_Shadow
posted Hide Post
quote:
Originally posted by PD:
quote:
Originally posted by Jimbo54:
Oh hell no!. BP medication is cheap, cheap. Why would anyone buy it from China.


Because you don’t know. Do you ask your pharmacist the country of origin of every refill you get? The doctor writes an Rx and the pharmacist fills it.

I went to RiteAide yesterday with my empty Valsartan bottle and the guy just shook his head. Said he’ll call my doc for a replacement and he did confirm it was a Chinese problem.

Fuck the FDA, too! The FDA release does not mention Chinese production.


Mine was definitely the Solco Valsartan made in China but it sounds like all were using the same base drug from China regardless of where they made the pill.


Wonder what else I have that originated there even in part.
 
Posts: 17871 | Location: SE Michigan | Registered: February 10, 2007Reply With QuoteReport This Post
Leave the gun.
Take the cannoli.
posted Hide Post
Doc’s office just called. Got switched to Losartan.
 
Posts: 6634 | Location: New England | Registered: January 06, 2003Reply With QuoteReport This Post
Member
Picture of erj_pilot
posted Hide Post
quote:
Originally posted by kz1000:
You'll wanna take it again 2 hours later...

I see what you're doing there...



Looks like one of my generic meds in the "original" container (not the yellow/orange container) is from India. Bothersome, because no telling what's in the orange containers for my other two generics.



"If you’re a leader, you lead the way. Not just on the easy ones; you take the tough ones too…” – MAJ Richard D. Winters (1918-2011), E Company, 2nd Battalion, 506th Parachute Infantry Regiment, 101st Airborne

"Woe to those who call evil good, and good evil... Therefore, as tongues of fire lick up straw and as dry grass sinks down in the flames, so their roots will decay and their flowers blow away like dust; for they have rejected the law of the Lord Almighty and spurned the word of the Holy One of Israel." - Isaiah 5:20,24
 
Posts: 11054 | Location: NW Houston | Registered: April 04, 2012Reply With QuoteReport This Post
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