Batches of Novomix 30 Flexpens and Penfill cartridges face European recall

[Northerner]

The European Medicines Agency said on Friday that some batches of Novo Nordisk's insulin products NovoMix 30 FlexPen and Penfill were being recalled because they might contain the wrong amount of insulin.

Due to a manufacturing problem during the filling of the cartridges, some contained too many or too few insulin units per millilitre, it said.

Only a very small proportion of cartridges - 0.14 percent - contain a wrong amount but in those affected the level of insulin may vary between 50 percent and 150 percent of the labelled dose.

The EU regulator said patients using products from the affected batches should be switched to supplies from unaffected batches or alternative treatments.

http://uk.reuters.com/article/2013/10/25/us-novonordisk-recall-idUKBRE99O0EE20131025

Not sure of the batch numbers affected yet as it hasn't appeared on the MHRA site, but I will update when it does. If you are worried then I would suggest contacting your pharmacy or Novo Nordisk.

Edit:
The numbers of the affected NovoMix 30 FlexPen batches are: CP50912, CP50750, CP50639, CP51706, CP50940, CP50928, CP50903, CP50914, CP50640, CP51095, CP50904, CP50650, CP51098, CP50915, CP50412, CFG0003, CFG0002, CFG0001, CP50902, CP50749, CP50393, CP50950, CP51025, CP50751, CP50375, CP50420, CP51097, CP50641, CP51096 and CP50392.

The numbers of the affected NovoMix 30 Penfill batches are: CS6D422, CS6C628 and CS6C411.

The batch numbers are printed on the pen for NovoMix 30 FlexPen and on the cartridge for NovoMix 30 Penfill.

 

[AlisonM]

Didn't we have a similar story a few weeks ago?

 

[AlisonM]

A yes, we did. Novorapid vials. Also, Bydureon. All because of under-filling issues.

 

[Northerner]

Affected batches:

The numbers of the affected NovoMix 30 FlexPen batches are: CP50912, CP50750, CP50639, CP51706, CP50940, CP50928, CP50903, CP50914, CP50640, CP51095, CP50904, CP50650, CP51098, CP50915, CP50412, CFG0003, CFG0002, CFG0001, CP50902, CP50749, CP50393, CP50950, CP51025, CP50751, CP50375, CP50420, CP51097, CP50641, CP51096 and CP50392.

The numbers of the affected NovoMix 30 Penfill batches are: CS6D422, CS6C628 and CS6C411.

The batch numbers are printed on the pen for NovoMix 30 FlexPen and on the cartridge for NovoMix 30 Penfill.

 

[everydayupsanddowns]

Seems like they are talking about the concentration of the insulin itself - so that 1u of the dodge carts might *actually* be only 0.5u in potency.

Is this because they dilute the actual insulin like orange squash at some point?!?

 

[Northerner]

Seems like they are talking about the concentration of the insulin itself - so that 1u of the dodge carts might *actually* be only 0.5u in potency.

Is this because they dilute the actual insulin like orange squash at some point?!?

I'm not sure. I know you can get 'high-strength' insulin that is used for patients who need especially high doses e.g. 500 units - perhaps that's how it all starts off!

 

[AlisonM]

They do indeed dilute the insulin. When you do your unit test before injecting, if you do, do you notice the smell of the fluid? That's a carrier liquid used in such things. It was in the Byetta and is in the Victoza I use as well as my insulin. the 'pure' serum is mixed with the carrier fluid, supposedly to the right levels for our use. I'm assuming that these problems have occurred because somewhere along the line the mixing process has been cocked up.

 

[trophywench]

Gosh - I always thought (like for over 40 years right up to now!) that the pong was the smell of insulin !

Weird that everyone uses exactly the same stuff, and that it's been the same stuff from Animal insulin right up till now.

Don't want to cast nasturtiums Alison, but are you sure?

 

[AlisonM]

Gosh - I always thought (like for over 40 years right up to now!) that the pong was the smell of insulin !

Weird that everyone uses exactly the same stuff, and that it's been the same stuff from Animal insulin right up till now.

Don't want to cast nasturtiums Alison, but are you sure?

Yup, I hate that smell. So I asked the consultant about it once and that was what he told me.