[b]USA ONLY![/b] - IBSA Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL

[helvella]

For wider interest - and in case we have anyone obtaining Tirosint-SOL in or from the USA.

Although all recalls are significant, it does not appear that this is a critical recall. And I have no idea if the recall could affect other countries - now or in future.

IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Subpotency

Company Announcement

IBSA Pharma Inc. is voluntarily recalling 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution to the consumer level. This voluntary recall has been initiated because these lots may be subpotent. The company’s analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots.

This recall does not apply to TIROSINT® (levothyroxine sodium) capsules.

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive subpotent TIROSINT®-SOL, 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. Over- or under-treatment with TIROSINT® SOL may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and glucose and lipid metabolism. Any patients including those who might be pregnant, newborn infants, or elderly patients, should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. To date, IBSA Pharma Inc. has not received any reports of adverse events that have been determined to be related to this voluntary recall.

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

[groovylady2017]

Oh damn! I did recently switch from Tirosint gel caplet to Tirosint Sol thinking I may have an absorption issue but I discontinued using the packet of solution tubes after a month. Felt like I wasn’t getting enough medicine out of the vials. I should check, I am in Los Angeles, CA!! No word from my own Endocrinologist from UCLA…wow! Thanks.

[helvella Administrator Thyroid UK in reply to groovylady2017]

Maybe put in an FDA report?

I honestly did not expect a single answer such as yours!

If the numbers in the recall are right, slightly below 95%, it could suggest that your dose is usually only just enough. So anything that increases your need (winter? exercise?) might easily knock you below.

[groovylady2017 in reply to helvella]

Yes so many factors to consider and yes I will do a report. Been on Tirosint for years, can’t handle the fillers, dyes in the other brands and have tried them all, here in US. It was a struggle indeed! Glad I posted and thank you. 😍

[EchoWS]

Thank you for posting - I just opened my new box of Tirosint included in the recall. Will be contacting the pharmacy.

[helvella Administrator Thyroid UK in reply to EchoWS]

Thanks for letting us know. Always good to hear that the post had its inetnded impact!