Crumbling Almus (Accord) 100 microgram tablets

[helvella]

My current batch of Almus (Accord) 100 microgram Levothyroxine tablets are extremely crumbly. Finding it difficult to get even one out without it breaking up.

For this reason, I have just filed a Yellow Card report - see below.

Much of my report has been pasted below.

If you are having this issue, or have another other medicine issue, you might consider raising a Yellow Card report.

yellowcard.mhra.gov.uk/

The attached picture is a composite of some that I sent to MHRA.

Incident and Product Details

Product name

Almus Levothyroxine Tablets

Strength (from label)

100 micrograms

Dosage form (tablet, capsule, cream, etc)

Tablets

Container type/size

28 tablet blister pack

Batch/lot number

TC1576

Expiry date (from label)

31/03/2022

Product licence number (from label, starting with PL or EU). Enter none if not applicable

PL 0142/0105

Legal status

POM

Supplier name

<redacted location>

Is sample available for MHRA arranged testing? Is sample available for MHRA arranged testing?

Yes

Has the supplier been contacted?

No

Please give details of the reported defect and details of any associated clinical incident

Many of the tablets are crumbling as they are removed from the blister packaging.

I am very familiar with this product, as I have taken this make for years, and only occasionally find I have broken a tablet. With this pack, three out of four have crumbled.

I have just tried to take another tablet out and it, too, has crumbled - photo attached.

I currently have two unopened and sealed packs of the same batch/expiry, if you wish to have them.

All packs were sealed when I collected them.

[MissGrace]

I have to split the 50mcg Almus to get my dose right. Some packets are okay, others a nightmare and disintegrate to dust. I have also had them splitting when coming out of the foil pack. Always put it down to me being a clumsy oaf - so glad to see it’s not just me and that packs do seem to vary! Would be interesting to know the reason for the inconsistency in the firmness of the tablet 🤸🏿‍♀️🥛

[helvella Administrator Thyroid UK in reply to MissGrace]

In years past, they would quite often break - maybe one or two per 28-tablet blister package.

Some time ago (a year or two, if I remember right), they seemed to be harder and never break. There was some discussion here suggesting some people were not absorbing the levothyroxine quite as well - but I seemed OK. It appeared that the factory had increased the pressure of the tablet compression machine.

As you also say, mine are breaking as I try to get them out of the blister pack. As I usually manage fine, I am blaming the product - and refuse to take any blame at all. (At one time I might have assumed it was me. But these tablets need to be usable by everyone from children to the very old. They simply must not assume everyone knows, or is even able, to eject the tablets with the delicacy of a watchmaker.

Please don't take any blame yourself. You might or might not be clumsy, I have no idea - but these things need to be usable by all. The pack doesn't say "Not for the clumsy".

(Me being bolshy. )

[Nanaedake in reply to helvella]

I've had that problem in the past with Actavis - a couple of years ago and no problems since but will now look out for it and do a yellow card if it happens.