Washington Post article says GSK quietly recallled and pulled Nicorette lozenges from US market a year ago

[Bill Godshall]

According to an article in today's Washington Post, GSK recalled Nicorette lozenges nationwide a year ago, but failed to inform consumers or the public why (as GSK simultaneously lobbied Obama’s FDA to demonize and ban nearly identical dissolvable tobacco lozenges, and far superior e-cigs)
http://www.washingtonpost.com/busin...8d19c6-ae37-11e4-abe8-e1ef60ca26de_story.html

This is the first I've heard about this, which indicates that GSK has gone to great lengths to keep this quiet.

 

[DrMA]

GSK came out with an announcement on Twitter the other day that the mini lozenges will be re-released "soon"

 

[SHOCK COLLAR]

I just converted a lozenger to a vaper because they were tearing thier stomach up. They are sooo happy now.

 

[xtwosm0kesx]

If i remember the article i read correctly they were removed due to inability to maintain quality control, ie there were some under/over dosed lozenges and there were problems with the consistency (some hard, some soft).

It hilarious one of the same things they're screaming about with e-cigs (lack of quality control) quietly went on at a big pharma plant for who knows how long.

again, Bizarro World.

 

[Endor]

If i remember the article i read correctly they were removed due to inability to maintain quality control, ie there were some under/over dosed lozenges and there were problems with the consistency (some hard, some soft).

It hilarious one of the same things they're screaming about with e-cigs (lack of quality control) quietly went on at a big pharma plant for who knows how long.

again, Bizarro World.

Wait. The FDA has direct oversight over a pharmaceutical company. Aren't they supposed to protect us from products not having the correct dosage?

 

[Bill Godshall]

Reynolds American (whose subsidiary Niconovum is selling FDA approved Zonnic nicotine lozenges for about $3 for 10 pieces) must be very pleased that GSK pulled their Nicorette lozenges just as Niconovum began marketing Zonnic nationwide last year.

 

[aikanae1]

This is such an unholy twisted web.

 

[Lessifer]

Wait. The FDA has direct oversight over a pharmaceutical company. Aren't they supposed to protect us from products not having the correct dosage?

I believe the pharma guidelines are that it must be within +-10% of the dosage that it's supposed to be, which is pretty noticeable when it comes to something like pain meds. If QC was off by more than that, with nic... I'm sure people were noticing it.

Also, I don't think the FDA oversees anything, the pharma companies do their own testing and submit their reports to the FDA, kind of like having students give their own grades.

 

[stevegmu]

I believe the pharma guidelines are that it must be within +-10% of the dosage that it's supposed to be, which is pretty noticeable when it comes to something like pain meds. If QC was off by more than that, with nic... I'm sure people were noticing it.

Also, I don't think the FDA oversees anything, the pharma companies do their own testing and submit their reports to the FDA, kind of like having students give their own grades.

That's kind of how manufacturing works. At work we don't have a DOT inspector checking samples... They do a yearly audit.

 

[Lessifer]

That's kind of how manufacturing works. At work we don't have a DOT inspector checking samples... They do a yearly audit.

I believe it's how most if not all regulated industries work, the USDA doesn't inspect every piece of meat, but I don't think the FDA actually performs any tests, only reviews the ones that have been submitted by the manufacturers.

Just pointing out a difference between what people think the FDA does, and what they actually do, and just how much that "FDA Approved" stamp means.

 

[somdcomputerguy]

..only reviews the ones that have been submitted by the manufacturers.

So some guy is saying to another guy, "You sent a batch to the FDA that was supposed to go on the store shelves..."

 

[Lessifer]

So some guy is saying to another guy, "You sent a batch to the FDA that was supposed to go on the store shelves..."

That would imply that the FDA actually does some testing. I believe what happens is, the manufacturer performs its own tests, then sends a summary report to the FDA for review.

This was a voluntary recall right? Initiated by the manufacturer, not due to some fda oversight.


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