General Discussion
Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsThe FDA has recalled two thyroid medications due to risks of contamination or "adulteration."
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 Westminsters products being recalled should call Westminsters 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
SCantiGOP
(13,871 posts)A lot of people take this medicine.
mucifer
(23,554 posts)Lugnut
(9,791 posts)I take 50 mcg a day.
CountAllVotes
(20,876 posts)Kick & recommend!
Greybnk48
(10,168 posts)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)which contains no information.
But...you can search for the med. and can also Google the med +recall, that will probably give info.
Ms. Toad
(34,076 posts)Not the separate meds.
Rhiannon12866
(205,552 posts)I take 75mcg of Levothyroxin daily. From this thread, looks like I'm not alone:
dixiegrrrrl
(60,010 posts)smirkymonkey
(63,221 posts)In fact I have a prescription to pick up at CVS in the next few days. Will have to ask them about it.
dixiegrrrrl
(60,010 posts)smirkymonkey
(63,221 posts)Rhiannon12866
(205,552 posts)I last got it refilled on 7/25 and I haven't heard a thing.
smirkymonkey
(63,221 posts)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.
Bayard
(22,103 posts)My dose is 50 mg, so I guess I'm okay?
Ms. Toad
(34,076 posts)Neither med, in separate pills is measured in mg. (I'm on both)
The recall is for a combo pill.
Aristus
(66,397 posts)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)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)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
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
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.