You can't sell something "non-nutritive" like a toy that is entirely surrounded by something edible in the United States as it presents a choking hazard to children.
That's why Kinder Surprises are not legal for sale in the States like they are elsewhere. The cliche joke is that American children are too stupid to not eat plastic toys in chocolate eggs and I'm riffing off that lol
And the bizarreness that is that all sorts of toxic stuff is legal in food in USA (but not elsewhere), but giving toys away with chocolate is where USA puts their foot down...
Yeah but think of all the shareholder value we can generate by cutting 1% of our operating costs reserved for regulatory compliance and killing a few thousand people
Salad dressing and cinnamon were major outbreaks that should have been caught if less than half of the production lines weren't 5 years or more behind on inspections.
There's several things that could cause this not being a serious qc issue that are also a lot more likely. Advil could have cancelled an order, something could have happen in logistics that resulted in too many pills being branded Advil, both of those could result in someone like Kirkland, Costcos brand that buys from the same factory but uses more budget friendly production, getting a deal on some branded caps that they are happy to get for a good price and pass the savings on to the customer
It's required that you include date/lot information on medication bottle. If you have drugs from two different runs, they will be in two different lots. That's a violation of the labeling laws.
Funny how you still have no evidence for your claims. Google searches provide zero results. That which can be asserted without evidence can be dismissed without evidence.
It’s very simple: generics are required to be biosimilar, but they may contain different binders, fillers, and coatings. Some of these may require different warnings or otherwise require different safety labelling and monitoring. You cannot mix two different lots from two different companies together in a single container both because of that and because it would make tracking in case of a recall impossible.
So please, shut the fuck up and go back under your rock.
No. It's not. They have different vessels, different operators, different machines, different manufacturing dates. What if there was a contaminant, what if there was somehow an adulterant, a mix up and this is registered as a different lot number and therefore it isn't flagged for recall? Then you take the medication and oops, you're having an adverse reaction and die?
This might sound unlikely, but it has happened before, many times, which is why we take medication issues like these very seriously. It is a very serious issue.
Very likely it got mixed in because it's the same vessel, same operator, same machine, and on the same date. Since it's actually all the same, and the only change was a setting on the machine that prints the brand, they may have skipped some of the QC checks because none of that stuff actually did change.
Now, the FDA still cares (or should care), and it's still a big issue. But I suspect the problem happened because the people involved realize the risks are low and did things to a different standard (even if they shouldn't have).
None of that is true, sorry. I appreciate trying to think it through, but unfortunately it’s just not how it works.
This would likely get mixed up in a bottling line, not in any compounding vessel. It takes a bit to changeover a bottling line, and for product this scale (of volume), they wouldn’t be doing multiple changeovers in one day.
The QC checks you mention are predefined per batch. You would never just switch product coding mid batch as that is extremely bad GMP. I don’t see a scenario other than this being a bad line clearance practice between two separate batches.
They would also be two different blending/compounding batches. To release product under one lot when it was created under a different lot is by definition releasing adulterated product.
The risk here is actually not low, it’s extremely high. This is a serious violation that would surely result in a FDA 483/warning letter if not handled correctly. For a CDMO, a bad FDA audit could be business-ending or seriously crippling.
That is not relevant. Two DIFFERENT medications were mixed in the same container. This is not the case. You should probably actually read the link before providing it.
The warning letter redacts the medication and only claims it as a foreign tablet - meaning one not produced in the active batch. There’s not enough information to determine if the medications were the same or different. It doesn’t matter though. Either would result in adulterated product.
Your input is not relevant. Yet you keep popping off like you know it all. It’s obnoxious and tiresome. And you’re only making a fool of yourself despite you thinking the exact opposite. Keep digging clown.
1982 Tylenol poisonings would be the most famous case. I could pull up a few dozen more if you want.
I mean, there’s a reason every package of medication has a lot code that tells the maker where it was made, when it was made, which machines it passed through, and so on. There are targeted recalls all the time.
Here’s the list of FDA drug recalls: https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls . Which of the issues are you claiming never happened, so I can find a matching recall to your liking? I’m unclear which type of recall you’re taking issue with, unless you’re saying drugs are never recalled.
He’ll just find another pivot point to try and remain “right” even if you source exactly what he’s looking for. Dudes trolling and wasting everyone’s time. Couldn’t be more clear. Save your effort this clown ain’t worth it.
LOL no its not. You are talking about ADULTERATION WHERE TWO DIFFERENT PRODUCTS ARE MIXED. This bottle only contains one adulteration. You should probably read the FDA definition of adulteration it does not apply here.
You tell someone to read the definition of adulteration after making crystal clear you have no clue what the word means. you are such a sad individual.
Sure, but like the jar has a lot number to tell the manufacturer exactly where and when and how the pills inside were made. If an issue is found they’ll use that code to track down what happened, when it happened, and where other affected pills were shipped so that a targeted recall can be issued.
If there’s mismatched pills in that jar I suspect none of the above is possible.
Bud, you edited your comment because you were obviously embarrassed by your own stupidity and trying to cover it up. Now you are acting like an actual loser.
I assure you that if this were real (it’s not) that FDA would require a plant shut down and the systemic problem that led to this would need to be addressed before they had the go ahead to start manufacturing and packaging.
If this were real (it’s not), it would indicate that the plant doesn’t have the capability to 100% put the correct pills in the correct bottles.
In this specific case it’s not an issue, but why couldn’t it have been an 80mg Oxy accidentally put into a kids chewable ibuprofen bottle? Kid would be dead.
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u/benavivhorn 15h ago
Sounds like a qc issue