ElMaestro
★★★

Belgium?,
2019-06-18 17:22

Posting: # 20337
Views: 1,217
 

 Recalled Paracetamol, a question for CMC gurus [Off Topic]

Hi all,

I noticed the news about recalled paracetamol .

If I get it right, the issue has been detected as a visible discolouration of the tablets .

Fungal species usually will not and do not overgrow anything anywhere unless there is a damp environment. So, I am guessing there is a lot of humidity in the affected bottles. This is not a little drop of water. Having fungus overgrowing tablets may imply a deluge of Biblical proportions.

It could come from the containers themselves or from the tablets. It could have arisen before, during, after the bottle filling. What is your best guess, how and/or when did the water enter this game in the first place?

A post-tabletting drum left in open air and suffering a rain shower? LOD testing done on some of the fortunate tablets prior to release? Or tested before the rain shower. And so forth, let me hear some wild speculation.:-)

I could be wrong, but...
Best regards,
ElMaestro
Helmut
★★★
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Vienna, Austria,
2019-06-18 18:40

@ ElMaestro
Posting: # 20338
Views: 1,158
 

 Recalled Paracetamol, a question for CMC gurus

Hi ElMaestro,

» A post-tabletting drum left in open air and suffering a rain shower? LOD testing done on some of the fortunate tablets prior to release? Or tested before the rain shower. And so forth, let me hear some wild speculation.:-)

Manufactured in the UK. Climate change? Monsoon-like conditions?

Cheers,
Helmut Schütz
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nobody
nothing

2019-06-18 20:44

@ Helmut
Posting: # 20339
Views: 1,144
 

 Recalled Paracetamol, a question for CMC gurus

Anyone with a photo of this "1x1000" tablet pots? Would love to see...

Kindest regards, nobody
ElMaestro
★★★

Belgium?,
2019-06-19 14:56

@ nobody
Posting: # 20342
Views: 1,074
 

 Recalled Paracetamol, a question for CMC gurus


I could be wrong, but...
Best regards,
ElMaestro
Helmut
★★★
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Homepage
Vienna, Austria,
2019-06-19 15:24

@ ElMaestro
Posting: # 20343
Views: 1,068
 

 Recalled Paracetamol, a question for CMC gurus

Hi ElMaestro?

» You can see it here

Green mold? Isn’t that some kind of algae?

Cheers,
Helmut Schütz
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ElMaestro
★★★

Belgium?,
2019-06-19 16:03

@ Helmut
Posting: # 20344
Views: 1,063
 

 Recalled Paracetamol, a question for CMC gurus

Haha,

» Green mold? Isn’t that some kind of algae?

Algae are good for you :-) This is apparently a combination product then.

I could be wrong, but...
Best regards,
ElMaestro
nobody
nothing

2019-06-19 16:04

@ ElMaestro
Posting: # 20345
Views: 1,062
 

 Recalled Paracetamol, a question for CMC gurus

Fake News, this is a Danish backyard, not in the UK... VERY SAD!

Kindest regards, nobody
ElMaestro
★★★

Belgium?,
2019-06-19 16:31

@ nobody
Posting: # 20346
Views: 1,052
 

 Recalled Paracetamol, a question for CMC gurus

» Fake News, this is a Danish backyard, not in the UK... VERY SAD!

Remember that companies are allowed to write "manufactured in the UK" on the PIL even if it is produced in India or Denmark or Tierra del Fuego, as long as the release is from someone in the UK.
So don't you come here and call my gonococci and slime molds and beautiful algae sad :-D

I could be wrong, but...
Best regards,
ElMaestro
nobody
nothing

2019-06-19 16:41

@ ElMaestro
Posting: # 20347
Views: 1,051
 

 Recalled Paracetamol, a question for CMC gurus

...you mean all these high-quality paracetamol products are produced in India, China, Indonesia or where ever and then simply LABELED as UK-products?

Wouldn't that be shocking? Some kind of... ...hhhmmmm.... fraught? 8-O

Kindest regards, nobody
Helmut
★★★
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Vienna, Austria,
2019-06-19 16:48

@ nobody
Posting: # 20348
Views: 1,046
 

 Recalled Paracetamol, a question for CMC gurus

Hi nobody,

» ...you mean all these high-quality paracetamol products are produced in India, China, Indonesia or where ever and then simply LABELED as UK-products?
»
» Wouldn't that be shocking? Some kind of... ...hhhmmmm.... fraught? 8-O

Acc. to EEA legislation: Manufactured in country A → released by a “qualified person” in European county B → officially manufactured in B. That’s it. Correct me if I’m wrong.

Cheers,
Helmut Schütz
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ElMaestro
★★★

Belgium?,
2019-06-19 17:10

@ Helmut
Posting: # 20349
Views: 1,033
 

 Recalled Paracetamol, a question for CMC gurus

Hi nobody and Hötzi,

» » Wouldn't that be shocking? Some kind of... ...hhhmmmm.... fraught? 8-O


Yes I find it highly misleading, too.

» Acc. to EEA legislation: Manufactured in country A → released by a “qualified person” in European county B → officially manufactured in B. That’s it. Correct me if I’m wrong.

That is exactly what it means.
I will be interviewed about such matters next week by a journalist who is sick and tired of some of the garbage we have to suffer in EU because the rules and regulations may be perceived as totally obscure and very much intended to protect regulators rather than patients.

What's more, you can't ask your doctor or at the pharmacy. They don't have such info either. For example,
"I don't want a Valsartan product where the active ingredient is from China because I heard it may be contaminated with carcinogens." - noone can help.
"I don't want a product manufactured in India, regardless of where it is released" - noone can help.
"I don't want a product approved on basis of a BE study done at GVK Bio or Semler" - noone can help.

I could be wrong, but...
Best regards,
ElMaestro
nobody
nothing

2019-06-19 17:40
(edited by nobody on 2019-06-19 18:12)

@ ElMaestro
Posting: # 20350
Views: 1,029
 

 Recalled Paracetamol, a question for CMC gurus

...if you don't want any products "produced" in China or India then start growing your own Herba Chamomill. in your backyard, otherwise you're lost... :-)

This legislation is imho 100% triggered by the manufacturers (generic+originators) to "improve economic conditions world-wide and trigger important investments in developing countries" (or what it would read like in the investors brochure).

___

PS:

MedWatch - The FDA Safety Information and Adverse Event Reporting Program
A MedWatch Safety Alert was just added to the FDA Recalls web page.

TOPIC: All Unexpired Sterile Drug Product Lots by Premier Pharmacy Labs: Recall - Due to Lack of Sterility Assurance

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: The unexpired sterile drug product lots are being recalled due to concerns presented during the latest FDA inspection including insufficient environmental controls, potential cross contamination and lack of product specific process validations. ....


Just the latest of these emails dropping in here frequently. It doesn'T matter where your medicine is fu** up eeehm produced. It'S the same sh** everywhere.

From their homepage:

"
STERILE COMPOUNDING PHARMACY

Premier Pharmacy Labs is committed to sterile compounding excellence. We were one of the first pharmacies in the United States to register as a 503B outsourcing facility (see FDA 503B). Premier has increased its resources and revenues towards expanding the sterile operations of our business. Adhering to GMP manufacturing standards is something new to all compounding pharmacies across the US and Premier is pushing to stay ahead of the mark with continued investment and innovation.
"

Kindest regards, nobody
nobody
nothing

2019-06-28 11:51

@ nobody
Posting: # 20365
Views: 774
 

 Recalled Paracetamol, a question for CMC gurus

PPS:

The FDA found termites, dead pests, impurities and other serious GMP violations at Bristol-Myers Squibb’s drug facility in Manati, Puerto Rico, during a Jan. 15-Feb. 6 inspection.

The agency investigators discovered that a media fill conducted at the facility resulted in a vial that was murky and contaminated with bacteria. The firm identified the contaminants as mites. As a result, lots of lyophilized drug products were placed on hold.

Kindest regards, nobody
jag009
★★★

NJ,
2019-07-01 02:41

@ ElMaestro
Posting: # 20367
Views: 719
 

 Recalled Paracetamol, a question for CMC gurus

Hi El,

» ... "I don't want a product approved on basis of a BE study done at GVK Bio or Semler" - noone can help.

Yup. You are stuck. Welcome to the... ^#@*!

John
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