NP Thyroid - Recall of certain lots

[asidist]

Hello,

I unfortunately haven't been able to get on here much recently but this FDA recall notice came through my email so wanted to share:

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency

fda.gov/safety/recalls-mark...

[helvella Administrator]

Thank you - that is helpful.

[lidoplace]

This seems a very small increase in potency - this notice proves this hormone product is regulated by FDA even if not licenced.

[helvella Administrator in reply to lidoplace]

This FDA-operated website lists all USA medicines and identifies statuses:

dailymed.nlm.nih.gov/dailymed/

Yes- NP Thyroid by Acella (or whatever precise name it now has) is on there.

[jendwall]

Yes, and the disappointing thing is that many changed over to NP Thyroid here in the States a few years ago because of the NatureThroid shortage/debacle. Many of our thyroid groups noticed the return of hypo symptoms/poor labs first with NatureThroid, and then eventually with NP Thyroid a couple of years later.

Current U.S. scenario is Armour is only working for some, and the rest of us have to take both synthetic levothyroxine (T4) and synthetic liothyronine (T3). Some are doing T3 only.

I wonder to myself often what in the world is going on with NDT (natural dessicated thyroid)? And prior to this NP Thyroid recall the only thing these companies admit is that the raw ingredient source location had changed, nothing else. Seems like they're not being very transparent What are they hiding? Many, many thyroid patients used to feel so much better on NDT, and it would be nice if we had some answers.

[Poniesrfun]

The Many articles posted online and the FDA recall notice calling this “super potentcy” make it sound really really scary when in reality it’s only a tiny amount of difference. The letter I received from Acella said this:

“The affected lots had levels of Liothyronine (T3) of up to 115.0% of the amount listed on the labels, which is outside of the acceptable range of 90.0 to 110.0%. The bottles affected include 30-mg, 60-mg, and 90-mg tablets from 13 batches that were produced in 2018 and early 2019.“

Normally, a one grain tablet may contain anywhere from 8.1 to 9.9 mcg of T3. The recalled tablets may contain 10.35 mcg of T3.

That’s a maximum difference of 2.25 mcg if a previous batch we took was at the very lowest end - not likely enough to cause thyrotoxicosis and all the horrible things that the FDA suggests unless someone is seriously overdosing their meds. And it could be only a 0.45 increase if our previous fill was at the upper end of “normal.

FDA uses the terms “sub-potentcy” and “super-potentcy” when a drug is below or above required specs But they and many people (and docs) don’t differentiate between a tiny variation or a double or triple dose when they see “Super”.

They have info similar to the letter on their website npthyroid.com/product-updates/

Patti in AZ

[EmbyLuz]

This is b.s. they are covering up contamination issues with their pills. The pills changed and smell strongly of cat urine and caused terrible stomach burning and bloat. I could not tolerate them and had to switch to armour. The potency claim is false as my labs never changed and other folks did not report this either. Now with the recall I can't find any info on sending tablets back and getting a refund.

[asidist in reply to EmbyLuz]

oh no! I hope there's some way to report that to the FDA or some other regulatory body

[helvella Administrator in reply to asidist]

Just as the the Yellow Card system exists in the UK, the FDA in the USA has...

MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.

fda.gov/safety/reporting-se...

I have no idea whether it is possible to report from outside the USA - or anything else about the system. And it might be sensible to be cautious about supplying any details about how you got hold of the product(s).

(A pity that Yellow Card didn't become more or less universal with each country using the same basic "branding" for their reporting systems.)

[asidist in reply to helvella]

thank you helvella! that’s SO helpful, i never knew about this.

actually have had some serious experiences with other (not directly thyroid related) drugs/procedures i’d like to report on from the past myself if not too late - will def be looking into it. thank you again