Friday 15 December 2017 11:39:52 PM

Important Health Notice: Diabetics Asked To Check Insulin Pens And Cartridges After Quality Concerns
More Storms Ahead For Dundrum Sea Wall October 27, 2013| Posted by | Comment on More Storms Ahead For Dundrum Sea Wall Comment

THE Medicines and Healthcare products Regulatory Agency (MHRA) today (Sunday asked people with diabetes to check their insulin pens or pen cartridges at home after a manufacturing fault has resulted in a precautionary recall across Europe of 33 specific batches of insulin pens and cartridges.

The products affected by the European recall are the NovoMix 30 Flexpen 100U/ml pre-filled pen and the NovoMix 30 Penfill 100U/ml cartridge. The manufacturing problem concerns a fault in the filling of the cartridges, which resulted in some batches of pens and cartridges containing too much or too little insulin.dn_screen

Information from the manufacturer shows that only around 0.14 per cent of the 3.3 million cartridges that are sold across Europe are likely to be affected by the manufacturing problem. Therefore, the safety risk to people with diabetes in the UK is likely to be limited to a small number of people.

People with diabetes or their carers can check to see if they have pens or cartridges from the affected batches by looking to see if the batch numbers are printed bewlow for the pen or cartridge.  

Gerald Heddell, the MHRA’s Director of Inspection, Enforcement and Standards, said: “Patients who use this product should check the batch numbers to see if their medicine is affected. If it is not listed as part of the recall, they should continue to take it as prescribed.

“Any patients with affected medicines should consult their GP or nurse to make arrangements for a new supply as soon possible.

“In the meantime, it is important that patients do not stop their treatment. They are advised to continue taking their medicine but to measure their blood glucose levels frequently to ensure adequate blood sugar control and that they are in close contact with their carer, a friend or family member who can get medical help if necessary. Patients who experience symptoms of hypo- or hyperglycaemia should contact a healthcare professional immediately.”

Simon O’Neill, Diabetes UK’s Director of Health Intelligence and Professional Liaison, said: “The important thing is that anyone affected by this must keep taking their insulin but should get it replaced at the earliest opportunity. We recommend people test their blood glucose levels regularly and be aware that their glucose levels may potentially run higher or lower.”

Affected batches     

Novomix 30 Penfill, Distributed in the UK by Novo Nordisk Ltd

Batch number

Expiry date

Pack size

Date of first distribution

CS6D422

Oct 2014

5 x 3ml

04 Jun 2013

CS6C628

Sep 2014

5 x 3ml

12 Apr 2013

CS6C411

Aug 2014

5 x 3ml

26 Mar 2013

Novomix 30 FlexPen, Parallel Distributed in the UK

Batch number

Expiry Date

Pack size

Date Shipped

CP50912

Oct 2014

5 x 3ml

04 Jun 2013

CP50750

Jul 2014

5 x 3ml

03 May 2013

CP50639

Jul 2014

5 x 3ml

16 Apr 2013

CP51706

Jan 2015

5 x 3ml

01 Oct 2013

CP50940

Oct 2014

5 x 3ml

28 Jun 2013

CP50928

Oct 2014

5 x 3ml

25 Jun 2013

CP50903

Oct 2014

5 x 3ml

04 Jun 2013

CP50914

Oct 2014

5 x 3ml

24 May 2013

CP50640

Jul 2014

5 x 3ml

16 Apr 2013

CP51095

Oct 2014

5 x 3ml

28 Jun 2013

CP50904

Oct 2014

5 x 3ml

07 Jun 2013

CP50650

Jul 2014

5 x 3ml

19 Apr 2013

CP51098

Oct 2014

5 x 3ml

28 Jun 2013

CP50915

Oct 2014

5 x 3 ml

29 May 2013

CP50412

Jul 2014

5 x 3ml

20 Mar 2013

CFG0003

Sept 2014

5 x 3ml

12 Jun 2013

CFG0002

Sept 2014

5 x 3ml

30 May 2013

CFG0001

Sept 2014

5 x 3ml

24 May 2013

CP50902

Oct 2014

10 x 3ml

31 May 2013

CP50749

Jul 2014

5 x 3ml

06 May 2013

CP50393

Jul 2014

5 x 3ml

08 Mar 2013

CP50950

Oct 2014

5 x 3ml

02 Jul 2013

CP51025

Oct 2014

5 x 3ml

21 Jun 2013

CP50751

Jul 2014

5 x 3ml

14 May 2013

CP50375

Jul 2014

5 x 3ml

15 Mar 2013

CP50420

Jul 2014

5 x 3ml

15 Mar 2013

CP51097

Oct 2014

5 x 3ml

28 Jun 2013

CP50641

Jul 2014

5 x 3ml

15 Apr 2013

CP51096

Oct 2014

10 x 3ml

28 Jun 2013

CP50392

Jul 2014

10 x 3ml

15 Mar 2013