NovoMix 30 Penfill 100U/ml, 3ml and NovoMix 30 FlexPen 100U/ml, 3ml – cartridges contain too much or too little insulin in batches

(Novo Nordisk A/S) Patients who may have received the affected batches should be contacted and asked to check their supply – class 2 action within 48 hours. (EL (13)A/25)

25 October 2013

Class 2 medicines recall

Action within 48 hours

Patient and pharmacy- level recall

MDR 63-10/13

Product details

Novo Nordisk A/S

NovoMix 30 Penfill, 100U/ml, 3ml, Suspension for Injection - EU/1/00/142/004

NovoMix 30 FlexPen , 100U/ml, 3ml, Suspension for Injection - EU/1/00/142/009

(Soluble insulin aspart / protamine insulin aspart 30% / 70%)

Alert details

Novo Nordisk A/S is recalling the batches listed in the table in Appendix 1 due to the possibility of a very small number of cartridges within each batch containing too much or too little insulin. We understand that the percentage of cartridges affected is approximately 0.14%.

Pharmacists are asked to quarantine any remaining stock from these batches. Patients who may have received the affected batches should be contacted and asked to check their supply. If they have any affected batches, they should be advised to contact their GP to request a new prescription and then return any stock from these batches only to their local pharmacy. Please see Appendix 2 for advice to patients and healthcare professionals

Remaining stock of the affected batches should be returned to the original supplier for credit. For enquiries relating to stock returns please contact  nncommercialopps@novonordisk.com, tel 01293 762091.

For medical information enquiries, please contact CustomerCare@novonordisk.com, tel 0845 600 5055.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

Appendix 1: 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

Appendix 2: Advice to patients and healthcare professionals

Advice to patients

Do not stop insulin treatment without consulting your doctor as it helps to control your blood sugar level.

If you are using a NovoMix 30 FlexPen or NovoMix 30 Penfill cartridges with a batch number not mentioned above you can continue treatment as usual.

If you are using a FlexPen or Penfill cartridge that has an affected batch number on it you should consult your GP or nurse to make arrangements for a new supply as soon possible. 

In the meantime:

  • continue to use your insulin
  • measure your blood sugar level frequently to ensure it is well controlled
  • be alert for signs and symptoms of hypoglycaemia (too little blood sugar) or hyperglycaemia (too much blood sugar)
  • keep in contact with an adult who can get medical help for you if necessary
  • if you experience any difficulties with your blood glucose control seek medical attention as appropriate
  • when new supplies have been obtained, return the affected products to your  pharmacy

Advice to pharmacists

Patients using a NovoMix 30 Penfill cartridges or a NovoMix 30 FlexPen that has one of the 33 affected batch numbers on it may be at increased risk of hypoglycaemia or hyperglycaemia.

The number of affected products present at patient level is thought to be very small.

Patients may attend the pharmacy with new prescriptions for NovoMix 30 Penfill cartridges or NovoMix 30 FlexPens.

Advise the patient to start using the new supply of FlexPens or Penfill cartridges immediately and return the affected cartridges to the pharmacy.

Advise the patient to monitor his or her blood glucose levels closely while switching to the newly prescribed FlexPen or Penfill cartridges, and to be alert for symptoms and signs of hypoglycaemia or hyperglycaemia.

Where for whatever reason no supply of replacement stock of NovoMix 30 Penfill cartridges or NovoMix 30 FlexPens can be made, advise the patient to continue to use the affected cartridges and to monitor their blood glucose levels  carefully, be alert for signs and symptoms of hypoglycaemia or hyperglycaemia and ensure they remain in contact with an adult who can offer help if needed and see your GP or specialist as soon possible.

Advice to GPs

Patients using a NovoMix 30 Penfill cartridge or a NovoMix 30 FlexPen that has one of the 33 affected batch numbers on it may be at increased risk of hypoglycaemia or hyperglycaemia.

The number of affected Penfill cartridges and FlexPens present at patient level is thought to be very small.

At this point there should be enough replacement stock available, if a patient reports having a Penfill cartridge or FlexPen that has one of the 33 affected batch numbers on it, supply a new prescription for NovoMix 30 Penfill or NovoMix 30 FlexPen that can be filled from non-affected batches and advise the patient to start using the new supply of product immediately.

Advise the patient to monitor his or her blood glucose levels closely while switching to the newly prescribed NovoMix30 cartridges or FlexPens, and to be alert for symptoms and signs of hypoglycaemia or hyperglycaemia. Ensure the patient has an adequate supply of testing strips .

Instruct the patient not to use any remaining Penfill cartridges or Flexpens that are affected and to return them to the pharmacy.

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