Class 2 Medicines Recall: Wockhardt UK Ltd, Levothyroxine 100micrograms/5ml Oral Solution EL(20)A/04

[helvella]

Your attention is drawn to a recall of one company’s Levothyroxine Oral Solution.

If you take any Levothyroxine Oral Solution, be aware. This recall could affect availability of all Levothyroxine Oral Solution products.

Class 2 Medicines Recall: Wockhardt UK Ltd, Levothyroxine 100micrograms/5ml Oral Solution EL(20)A/04

Wockhardt UK Ltd is recalling specific batches of Levothyroxine 100micrograms/5ml Oral Solution from pharmacies and wholesalers as a precautionary measure due to notification of the impurity liothyronine exceeding the specification limit.

Follow the link below for full information:

gov.uk/drug-device-alerts/c...

Although this recall is a serious matter, surely many of us can see a bitter irony in the reason for the recall?

Added:

Further posts on same issue:

healthunlocked.com/thyroidu...

healthunlocked.com/thyroidu...

healthunlocked.com/thyroidu...

[marram]

I was a little confused on the Liothyronine connection, as it is Levothyroxine only. But it has been confirmed to a friend who called that triiodothyronine (T3) is a breakdown product of Levothyroxine as it starts to degrade. I also found this study which us interesting, confirming that fact.

cris.brighton.ac.uk/ws/port...

[helvella Administrator Thyroid UK in reply to marram]

Yes - levothyroxine can degrade to T3, just like conversion!

We do not know, and cannot tell, whether this is liothyronine impurity from manufacture of the active pharmaceutical ingredient, or degradation during manufacture, during storage and distribution, or simply over time before expiry date.

It would have been good to know how much liothyronine (T3) has been found in this product. As it stands, we have no idea if it is 1% over the limit - or several times the limit. Indeed, we do not even know what that limit is. For tablets, it is 1% of the claimed potency. E.g. 1 microgram in a 100 microgram levothyroxine tablet.

[marram in reply to helvella]

The pharmacist said it was degrading too quickly due to something during manufacture. There could not have been very much, because my friend is VERY sensitive to really tiny amounts of T3. I have learned something today though! I was tempted to ask her to pass on a bottle for me to hold on to in case I cannot get my usual T3.! One person on FB said it is not true that Levo breaks down into T3, and insisted Thyroid UK had stated it was a typo. I cannot find such a statement, to be honest. But my little research today has confirmed that it is correct, not a typo.

[helvella Administrator Thyroid UK in reply to marram]

Facebook says lots of things!

It is quite clear that levothyroxine can, and does, degrade to T3:

AAPS PharmSciTech. 2010 Jun; 11(2): 818–825.

Published online 2010 May 8. doi: 10.1208/s12249-010-9434-8

PMCID: PMC2902299

PMID: 20454876

Influence of Formulation and Processing Factors on Stability of Levothyroxine Sodium Pentahydrate

Jarrod W. Collier, Rakhi B. Shah, Abhay Gupta, Vilayat Sayeed, Muhammad J. Habib, and Mansoor A. Khancorresponding author

ncbi.nlm.nih.gov/pmc/articl...