25 October 2013
Class 2 medicines recall
Action within 48 hours
Patient and pharmacy- level recall
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%)
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 firstname.lastname@example.org, 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.