Medicine from China -Now FDA recalled mine

June 27, 2018, 10:47 AM

sjtill

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

June 27, 2018, 10:53 AM

jhe888

The FDA tries, but I'm not sure how effective they can be. I'd avoid it.

June 27, 2018, 11:02 AM

EasyFire

Nope...nope...nope. Why is this even a consideration?

June 27, 2018, 04:46 PM

arfmel

Because it’s cheaper for the insurance company, probably.

June 27, 2018, 04:50 PM

HRK

take it back, tell them "no msg"

June 27, 2018, 04:56 PM

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.

June 27, 2018, 06:31 PM

wrightd

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.

July 17, 2018, 02:29 AM

Oz_Shadow

Original post updated - FDA recall of the one I got!

July 17, 2018, 06:37 AM

ScreamingCockatoo

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.

July 17, 2018, 09:32 AM

henryaz

quote:
Originally posted by 12131:
Chinese med's side effect: impotence.

You're supposed to order some powdered rhinoceros horn with the meds.

July 17, 2018, 10:19 AM

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.

July 17, 2018, 10:41 AM

Censored

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

July 17, 2018, 08:33 PM

fgwilliams1

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.

July 18, 2018, 04:37 AM

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.

July 18, 2018, 05:18 AM

eltonr

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.

July 18, 2018, 06:17 AM

Oz_Shadow

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.