NP Thyroid Recall

NickNack · ‎03-10-2010

I know some of you take NP Thyroid, and I got this notice of a recall today and wanted to share.

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: NP Thyroid (Thyroid Tablets USP) by Acella Pharmaceuticals: Recall - Due to Subpotency

AUDIENCE: Patient, Health Professional, Endocrinology

ISSUE: Acella Pharmaceuticals is recalling one lot of 15 mg and one lot of 120 mg NP Thyroid (Thyroid Tablets USP) because testing has found these lots to be subpotent.

Patients being treated for hypothyroidism (underactive thyroid), who receive subpotent NP Thyroid, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.

The affected products include:

NP Thyroid 15 - Lot Number: M327E19-1
NP Thyroid 120 - Lot Number: M328F19-3

To date, Acella has received four reports of adverse events for these lot numbers possibly related to this recall.

For product photos and labels click the "Read Recall" button below.

BACKGROUND: NP Thyroid (Thyroid Tablets USP) is composed of levothyroxine and liothyronine and used to treat hypothyroidism (underactive thyroid).

RECOMMENDATION: Patients who are currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

The Bluebird Carries The Sky On His Back"
-Henry David Thoreau

Nightowlz · ‎03-11-2010

Thanks for sharing since I do take NP Thyroid.

They just had a recall for several different lots that had too much T3 in them. They were pills mfg 2018-2019.

I think I took those for about a year. My heart was beating too fast plus jittery while I was taking those.

My labs came back showing I needed to take more. I told my doctor at that time I could not take anymore. Now I know why.

Glad the 90mg was not recalled on this new recall.

I figure eventually I will end up back on levothyroxine or Synthroid since I'm tired of dealing with the Recalls.

debcakes · ‎03-11-2010

Naturethroid has also been recalled. I am still taking it and have not called my doctor, yet. My recent blood work shows very good levels, so maybe it's ok for me.

tsavorite · ‎03-09-2010

@Nightowlz This is such a issue with these thyroid meds...over the yrs for me either I can't get it at all due to a "shortage" for varying reasons or they changed the formula (Armour) and ruined a great product! The Armour now is terrible and I could take a super high amount and still be sick/hypo. NOt to mention the COST....is OUT OF SIGHT.

For the past 15yrs it has been a roller coaster on my thyroid medication due to this. Heck right now I am on Tirosint and I do not like it. The endo gave me lot's of samples as it is very expensive....I did order thur the manufactures site to get it cheaper but $40 a month is not inexpensive. My TSH is hypo high and my T4 is in the middle of the range...for some reason she won't test my FT3 which I suspect is very low and would explain the high TSH. I am not converting. So I am going back to my former internist to get his opinion and re-do my labs. I feel hypo sick all the time for months on this other medication.

Perhaps I need T3 added in with this....I will find out this week. But I really don't want to go back to the natural forms of thyroid due to the constant stress of it being recalled/reformulated or not available.

Nightowlz · ‎03-11-2010

@tsavorite wrote:
@Nightowlz This is such a issue with these thyroidmedss...over the yrs for me either I can't get it at all due to a "shortage" for varying reasons or they changed the formula (Armour) and ruined a great product! The Armour now is terrible and I could take a super high amount and still be sick/hypo. NOt to mention the COST....is OUT OF SIGHT.

For the past15yrss it has been a roller coaster on my thyroid medication due to this. Heck right now I am onTirosintt and I do not like it. Theendoo gave me lot's of samples as it is very expensive....I did orderthurr the manufactures site to get it cheaper but $40 a month is not inexpensive. MyTSHH is hypo high and myT44 is in the middle of the range...for some reason she won't test myFT33 which I suspect is very low and would explain the highTSHH. I am not converting. So I am going back to my former internist to get his opinion and re-do my labs. I feel hypo sick all the time for months on this other medication.

Perhaps I needT33 added in with this....I will find out this week. But I really don't want to go back to the natural forms of thyroid due to the constant stress of it being recalled/reformulated or not available.

@tsavorite

I used to take Armour. I switched when they reformulated & my TSH was over 70?

The NP Thyroid is like the old Armour but less ingredients. It works better for me than Armour. I like I can take it sublingually. I could not do that with Armour after their reformulation. It was like having a mouth full of chalk.

Before I went to NP Thyroid I used Erfa from Canada which is like Armour until they started having issues years later. The price tripled plus was unavailable so I switched to NP Thyroid.

I paid less than $100 for 500 tablets of the Erfa from Canada.

Now I'm paying about $80 with Good Rx coupon for 3 month supply. My Ins will no longer pay for it.

I did take levothyroxine years ago. I was always tired, gaining weight, retaining fluid. Back than all the doctors wanted to keep your TSH at 4-5 range??? Now they want to keep it at 1.

I had to look upTrosint. Did not know it was capsule form of levothyroxine.

I don't like how the doctors won't run tests you need when taking natural thyroid. I guess I just give up. They test what they want. So long as I fill ok guess I'm good with that. I have a new doctor now so don't know how he will be. I'm sick of dealing with it. At least I feel better on NP Thyroid so long it does not have too much T3 in it.

The only doctors I ever had that ran the tests you need are all retired now. All doctors now want me to switch.

I'm wondering if there will be shortages due to Pandemic? I know the active ingredient in NP comes from New Zealand. Not sure where the other brands come from.

tsavorite · ‎03-09-2010

@Nightowlz Same thing for me....I switched yrs back to EFRA and it was working but expensive. Then I went on Nature thyroid....was doing ok then they had a shortage. Doctor put me on levo and then I had issues.

I am tired of the mess with thyroid medications being reformulated or recalled. It is very upsetting and stressful. I hope I can go on synthroid and some T3 perhaps...if that works and I can afford it fine BUT who knows. I will keep the NP thyroid in mind....if has good availability.

So many people have thyroid disease it is the second to diabetes...you would think these medicines would be secure and stable as the demand is so high.

I just need to get on the correct one so I can feel as well as possible and stop all the madness of changing it.

And yes the TSH at 4-5 or higher is common with lot's of doctors...endo's for sure! She told me I was barely hypo and my TSH at last labs was almost 6. Now that it's at 4+ I am normal!

Thank goodness my former internist is younger then I am by a few yrs and tests correctly and will work to get me feeling better on something. I never dreamed having this disease (hash's) would be so much of a PITA in my life...and finding a good doctor is hard...not many out there.

Nightowlz · ‎03-11-2010

@tsavorite wrote:
@Nightowlz  Same thing for me....I switched yrs back to EFRA and it was working but expensive. Then I went on Nature thyroid....was doing ok then they had a shortage. Doctor put me on levo and then I had issues.

I am tired of the mess with thyroid medications being reformulated or recalled. It is very upsetting and stressful. I hope I can go on synthroid and some T3 perhaps...if that works and I can afford it fine BUT who knows. I will keep the NP thyroid in mind....if has good availability.

So many people have thyroid disease it is the second to diabetes...you would think these medicines would be secure and stable as the demand is so high.

I just need to get on the correct one so I can feel as well as possible and stop all the madness of changing it.

And yes the TSH at 4-5 or higher is common with lot's of doctors...endo's for sure! She told me I was barely hypo and my TSH at last labs was almost 6. Now that it's at 4+ I am normal!

Thank goodness my former internist is younger then I am by a few yrs and tests correctly and will work to get me feeling better on something. I never dreamed having this disease (hash's) would be so much of a PITA in my life...and finding a good doctor is hard...not many out there.

@tsavorite

I figure if I go back to levo I won't have any energy, retain fluid, gain weight just like I did years ago.

I feel better on NP Thyroid so I'm sticking with it for now.

I don't understand all the reformulations since they should not reformulate something that works?

So far I have not had any problems getting NP. The only issues with it so far was the batches that had too much T3 & now the batches that don't have enough active.

A TSH of 4+ is not in the range it should be. They have kept mine around 1 for years. You will still feel tired with it there. Years ago the doctors kept it 4-5 range so I was always tired. The younger doctors keep it at 1.

I never dreamed it would be so difficult either plus frustrating trying to find a doctor that will run all the tests you need.

I feel so much better with it at 1 or so.

Since I'm off the stuff with too much T3 I need to get labs so I can make sure I'm taking what I need now.