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dixiegrrrrl

(60,010 posts)
Sat Aug 18, 2018, 11:39 PM Aug 2018

The FDA has recalled two thyroid medications due to risks of contamination or "adulteration."

The medications, Levothyroxine and Liothyronine, are being recalled in their tablet form in the 15 mg, 30 mg, 60 mg, 90 mg and 120 mg dosages.

The company for both medications is Westminster Pharmaceuticals, LLC.

Customers and patients with medical-related questions, information about an adverse event or other questions about the Westminster’s product’s being recalled should call Westminster’s Regulatory Affairs department at (888) 354-9939.


the above is the whole news statement..
http://www.nbc-2.com/story/38891422/fda-recalls-2-thyroid-medications-for-contamination-concerns
19 replies = new reply since forum marked as read
Highlight: NoneDon't highlight anything 5 newestHighlight 5 most recent replies
The FDA has recalled two thyroid medications due to risks of contamination or "adulteration." (Original Post) dixiegrrrrl Aug 2018 OP
K & R SCantiGOP Aug 2018 #1
that's weird Levothyroxine is in mcg not mg. mucifer Aug 2018 #2
That's what it says on my bottle of pills. Lugnut Aug 2018 #9
Kick & recommend! CountAllVotes Aug 2018 #3
I'm on 25 mcg. of Levothyroxine a day Greybnk48 Aug 2018 #4
There is a link at the story that takes you to the FDA page, dixiegrrrrl Aug 2018 #7
The recall is for a combo pill. Ms. Toad Aug 2018 #14
Thanks! Just checked mine Rhiannon12866 Aug 2018 #15
Good info....ty! n/t dixiegrrrrl Aug 2018 #18
Damn. I take both of them. I haven't heard anything about it yet. smirkymonkey Aug 2018 #5
Pls. see my reply just above you. n/t dixiegrrrrl Aug 2018 #8
Thank you! smirkymonkey Aug 2018 #11
I take Levothyroxin, 75mcg daily. Rhiannon12866 Aug 2018 #16
I take 137mcg per day and 25mcg of liothyronine. smirkymonkey Aug 2018 #17
Levothyroxine Bayard Aug 2018 #6
Mcg, not mg. Ms. Toad Aug 2018 #13
Nice going, Westminster... Aristus Aug 2018 #10
Inaccurate info. Ms. Toad Aug 2018 #12
They better be recalled if they were 15 milligram pills! moriah Aug 2018 #19

Greybnk48

(10,168 posts)
4. I'm on 25 mcg. of Levothyroxine a day
Sun Aug 19, 2018, 12:05 AM
Aug 2018

for hypothyroidism. I haven't been notified about my meds. at that dosage, at least not yet. I'm going to check with my pharmacy tomorrow. Thanks.

dixiegrrrrl

(60,010 posts)
7. There is a link at the story that takes you to the FDA page,
Sun Aug 19, 2018, 01:18 AM
Aug 2018

which contains no information.

But...you can search for the med. and can also Google the med +recall, that will probably give info.

Rhiannon12866

(205,552 posts)
15. Thanks! Just checked mine
Sun Aug 19, 2018, 05:47 AM
Aug 2018

I take 75mcg of Levothyroxin daily. From this thread, looks like I'm not alone:

 

smirkymonkey

(63,221 posts)
5. Damn. I take both of them. I haven't heard anything about it yet.
Sun Aug 19, 2018, 12:29 AM
Aug 2018

In fact I have a prescription to pick up at CVS in the next few days. Will have to ask them about it.

 

smirkymonkey

(63,221 posts)
17. I take 137mcg per day and 25mcg of liothyronine.
Sun Aug 19, 2018, 09:56 AM
Aug 2018

I had a doctor in NY who took me off them once and it was a disaster. I was so tired and lethargic I could barely walk two blocks without wanting to go back to bed.

Ms. Toad

(34,076 posts)
13. Mcg, not mg.
Sun Aug 19, 2018, 02:30 AM
Aug 2018

Neither med, in separate pills is measured in mg. (I'm on both)

The recall is for a combo pill.

Aristus

(66,397 posts)
10. Nice going, Westminster...
Sun Aug 19, 2018, 01:37 AM
Aug 2018


CEO's skimming so much off the top that the QA department is losing ground? Putzes...

Levothyroxine is a medication I prescribe for many of my patients. They'd better fix this, but fast!

Ms. Toad

(34,076 posts)
12. Inaccurate info.
Sun Aug 19, 2018, 02:28 AM
Aug 2018

Recall is voluntary by the company, not the FDA, for a single pill that combines both meds (AND the dose for the separate meds is measured inmcg, not mg (which is a big clue not to trust anything in the article . . ., Or the company-since either the combo pill contains vastly different quantities of meds-or it screwed up it's recall notice)

https://www.fda.gov/Safety/Recalls/ucm616601.htm

ETA looks like the combo med dose does contain 10x the meds of the separate pills.

moriah

(8,311 posts)
19. They better be recalled if they were 15 milligram pills!
Sun Aug 19, 2018, 01:58 PM
Aug 2018

That's a helluva lot of thyroid go juice, would cause serious adverse events!

On the serious, I know it was sloppy typing in the FDA release. I want to know what the alleged contaminant is, though.... which they don't give much information on.

https://www.fda.gov/Safety/Recalls/ucm616601.htm

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Manufacturing Practices (cGMP). Substandard cGMP practices could represent the possibility of risk being introduced into the manufacturing process.

To date, Westminster Pharmaceuticals has not received any reports of adverse events related to this product.

Levothyroxine and Liothyronine (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. Thyroid tablets contain both tetraiodothyronine sodium (T4 levothyroxine) and liothyronine sodium (T3 liothyronine). Levothyroxine and Liothyronine tablets (thyroid tablets, USP) are indicated as replacement or supplemental therapy in patients with hypothyroidism. Appropriate adjustments of the various therapeutic measures directed at these concomitant endocrine diseases are required. Thyroid is not associated with serious adverse reactions and does not have a known tumorigenic potential.

Because these products may be used in the treatment of serious medical conditions, patients taking the recalled medicines should continue taking their medicine until they have a replacement product.


Here's the link about the "Sichuan Friendly Pharmaceutical Company":

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm612389.htm

Your firm failed to conduct residual solvent testing of your active pharmaceutical ingredient (API), (b)(4) USP, distributed to the United States.

For example, you did not test for residual solvent levels (e.g., (b)(4)) in your intermediate or finished (b)(4) API batches in order to determine whether results fell within acceptable levels.

You also manufacture this API on shared equipment. Multiple API are produced on this equipment and use other solvents, including (b)(4), a class 2 solvent. Class 2 solvents must be limited because of their inherent toxicity and controlled to protect patients from potential adverse affects.
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