Are drug recalls usually kept secret?

Started by atticus27
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atticus27

atticus27

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ETHEX Corporation has initiated a nationwide recall of Metoprolol Succinate because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices and more importantly, due to defects found, including oversized tablets delivering higher than labeled doses.

Those dirty bastards. How come the public doesn't get notified about this?
 
recalls happen all the damn time...unless there's cyanide in the tablets, no major news organization is going to pick it up. It's just another 😴 story.
 
atticus27 said:
ETHEX Corporation has initiated a nationwide recall of Metoprolol Succinate because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices and more importantly, due to defects found, including oversized tablets delivering higher than labeled doses.

Those dirty bastards. How come the public doesn't get notified about this?
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They are...you just have to look for it. There are so many drug recalls, it's impossible to expect the media to report them all...unless it was a gigantic one that leads to deaths...ala that peanut butter thing last month or so.
 
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I see what you guys are saying, but I know I would be more inclined to read a story on recalled pharmaceuticals, especially if I was on meds, than about a woman who shopped at Target on a horse. Who cares about that anyways? Are you kidding me?

Besides, ignoring these issues due to their frequency makes it too easy on the manufactureres who pull this kind of stuff.
 
AstraZeneca, "hey FDA manager, I can get your wife a good job with us if you'll look into ETHEX's manufacturing quality."

FDA manager, "Ok, we'll look into it!"

FDA manager's wife, "So you see doctor, Toprol XL is clearly the choice for "*cough*-label" use in treatment of anything and everything, here's some pens for you and don't forget about our CE program in the Bahamas!"

I'm just being cynical, but then again it could be exactly how it went down.
 
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Recalls are never kept secret because HCPs get notified. And anyone who wants to sign up for the distribution list at the FDA website is also notified.

There are, as you may or may not know, three classes of recalls, and there are rules for each one. On a Class III recall there is a) no need to notify general public b) there will be more harm from notifying general public because average Joe or Jane is stupid, and won't understand what's going on, will panic, and may stop taking perfectly good medication because s/he doesn't understand what's going on.

And media is rarely your friend when it comes to publicizing healthcare issues... reporters are just as uneducated about healthcare as the average Joe, and also their job isn't to inform to public, it is to sell papers/magazines. So they will sensationalize the heck out of it and scare people needlessly about every little thing... that's why manufacturesrs and government communicate recalls directly to HCPs, unless involvement of general public is absolutely necessary.
 
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Fuzzychickens said:
AstraZeneca, "hey FDA manager, I can get your wife a good job with us if you'll look into ETHEX's manufacturing quality."

FDA manager, "Ok, we'll look into it!"

FDA manager's wife, "So you see doctor, Toprol XL is clearly the choice for "*cough*-label" use in treatment of anything and everything, here's some pens for you and don't forget about our CE program in the Bahamas!"

I'm just being cynical, but then again it could be exactly how it went down.
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Very naive. The whole factory that manufacturers a range of products was shut down. It's not just metoprolol which is affected, but also oxycodone, and some other drugs I cannot immediately recall. KV/Ethex is the third high-profile generic factory shutdown due to gross violation of GMP in the recent months, with Actavis and Ranbaxy being the other two... maybe there are more, but these ones stuck in my memory. No shortage of branded recalls either, but those are usually limited lot recalls - these are whole factory closings.
 
I used to get at least 2 notices for recalls. One from the manufacturer and the other from the wholesaler. It's not kept secret at all.
 
Hels2007 said:
Very naive. The whole factory that manufacturers a range of products was shut down. It's not just metoprolol which is affected, but also oxycodone, and some other drugs I cannot immediately recall. KV/Ethex is the third high-profile generic factory shutdown due to gross violation of GMP in the recent months, with Actavis and Ranbaxy being the other two... maybe there are more, but these ones stuck in my memory. No shortage of branded recalls either, but those are usually limited lot recalls - these are whole factory closings.
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In the last few years GSK had a plant closed in Puerto Rico that caused shortages of Avandamet and Paxil CR and Purdue Fredricks had a plant closed down that caused a shortage of Senokot among other things. Greed and mismanagment is not the sole provence of the generic industry....
 
ItsOverZyvox said:
I used to get at least 2 notices for recalls. One from the manufacturer and the other from the wholesaler. It's not kept secret at all.
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I get three: FDA, wholesaler, manufacturer. Anyone can sign up for notices on the FDA website and they will innudate your mailbox with everything from peanut butter to Plavix. It's very exciting stuff...😴
 
It was publicized in the local newspaper, I had a few people call the pharmacy. For the Ethex recall, our patients who had a prescription for the drug actually received letters from the manufacturer also. Recalls just gets lost in the news, and the sheer number of recalls every week becomes numbing after a while.
 
ItsOverZyvox said:
I used to get at least 2 notices for recalls. One from the manufacturer and the other from the wholesaler. It's not kept secret at all.
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Right, but you're a pharmacist. The "arbitrary" recall info isn't sent to Joe Schmo the patient.

pharmacyanalyst said:
It's very exciting stuff...😴
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What! If YOU were not young and healthy and you found out the lab that makes your meds has been f'in up the dosage and subsequently shut down for faulty practices I doubt you would find it a snooze fest.
 
Megas said:
It was publicized in the local newspaper, I had a few people call the pharmacy. For the Ethex recall, our patients who had a prescription for the drug actually received letters from the manufacturer also. Recalls just gets lost in the news, and the sheer number of recalls every week becomes numbing after a while.
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I'm impressed that the local paper and Ethex tried to notify patients, but that's just for that select area right? I just found an article about Sandoz's metoprolol recall with a bunch of people pissed off at everyone involved including M.D.'s and RPh's.

Sandoz Metoprolol Succinate ER Tablets Recall Has Been Done Rather Quietly

Many Patients Are Dissatisfied With Lack Of Information From Sandoz, FDA, Or Their Pharmacy About Why This Generic Toprol Pill Was Pulled
http://www.drug-injury.com/druginju...lina-generic-drug-manufacturing-facility.html
 
atticus27 said:
What! If YOU were not young and healthy and you found out the lab that makes your meds has been f'in up the dosage and subsequently shut down for faulty practices I doubt you would find it a snooze fest.
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Lord, calm down. Maybe you need to take one of those pills and READ THE ENTIRE POST!:uhno: I was talking about all the recalls the FDA will send you if you sign up. Sorry if I offended you because I don't enjoy reading about recalled fish, deodorant and nuts all day long.
 
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atticus27 said:
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I see what you guys are saying, but I know I would be more inclined to read a story on recalled pharmaceuticals, especially if I was on meds, than about a woman who shopped at Target on a horse. Who cares about that anyways? Are you kidding me?

Besides, ignoring these issues due to their frequency makes it too easy on the manufactureres who pull this kind of stuff.
Click to expand...

As long as we're citing the top news of the day...60-foot penis painted on roof
 
atticus27 said:
I'm impressed that the local paper and Ethex tried to notify patients, but that's just for that select area right? I just found an article about Sandoz's metoprolol recall with a bunch of people pissed off at everyone involved including M.D.'s and RPh's.

Sandoz Metoprolol Succinate ER Tablets Recall Has Been Done Rather Quietly

Many Patients Are Dissatisfied With Lack Of Information From Sandoz, FDA, Or Their Pharmacy About Why This Generic Toprol Pill Was Pulled
http://www.drug-injury.com/druginju...lina-generic-drug-manufacturing-facility.html
Click to expand...

I'm sure notification for patients may have been spotty. The local paper (which comes out twice a week) covers small stuff, boy scouts, cow tipping, drug recalls; not much else happpen.
 
pharmacyanalyst said:
Lord, calm down. Maybe you need to take one of those pills and READ THE ENTIRE POST!:uhno: I was talking about all the recalls the FDA will send you if you sign up. Sorry if I offended you because I don't enjoy reading about recalled fish, deodorant and nuts all day long.
Click to expand...

I AM CALM DAMMIT! lol :laugh: jk
 
Hels2007 said:
Very naive. The whole factory that manufacturers a range of products was shut down. It's not just metoprolol which is affected, but also oxycodone, and some other drugs I cannot immediately recall. KV/Ethex is the third high-profile generic factory shutdown due to gross violation of GMP in the recent months, with Actavis and Ranbaxy being the other two... maybe there are more, but these ones stuck in my memory. No shortage of branded recalls either, but those are usually limited lot recalls - these are whole factory closings.
Click to expand...

It was a joke, by the way, what I said mirrors how Wyeth behaves towards compounding and my drug rep example is very much the way Neurontin was marketed (what got them fined, but they still made a profit off illegal marketing overall).

So really, it's pretty easy to be cynical. And if it turns out there was bias in favor of the brand name companies on these factory shutdowns, I would not be surprised.
 
Hibiclens said:
Don't slam me for saying this...but I'd say most recalls are pointless. True?
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Absolutely not. Two recent examples:

1) Daytrana patches: difficulty in removing the liner of the patch, which allows the drug to be released for absorption. If you're unable to remove the liner, then the patch is useless.

2) Digitek tablets: recently found to contain double the amount of digoxin indicated. Obviously, consistently doubling a dose of digoxin can lead to terrible issues.

There are many, many more examples to cite. These are just cases that are fresh in my mind.
 
pharmacyanalyst said:
I'd say false too but there are different classes of recalls. I believe the digitek recall was a Class I ??
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Yeah, there are a few different classes (not sure how many, though). Digitek was a class I because it had a significant chance of creating patient harm. Other recalls are due to issues that might cause waste or inconvenience, like the Daytrana patch recall.
 
Usually, people never find out about the voluntary recalls. When the FDA starts pulling stuff, that's when it gets nasty. I guess the main reason why people found out about this was because a lot of pharmacies ran out of the stuff, and couldn't order any other generics.

And then they had to call up the physicians and have them change to Lopressor, which took forever, and then like 2 weeks after the physicians call back, we get a boatload of generic Toprol XL in the order.
 
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Hels2007 said:
You've got some generic? We were still out this weekend, don't know if anything came this week...
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Yeah, last time I checked, we were fully stocked on the stuff. Stores have been sending patients here or have been requesting a few bottles.

It's not Sandoz, I forget who the manufacturer is for this one but I'm almost certain that it is the same guys who make the brand name Toprol XL, basically they are doing what the manufacturers of Protonix did with their generic.
 
At the Walgreens I work at (as a tech), we never give the reason why a medication was recalled. I find that an ethical issue, especially when the customer is pushing to know, but that's what we're supposed to do. *shrug*
 
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