GovWire

MDR Number

MDR 200-05/22

Company name

Novo Nordisk Limited

Product description

NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen (insulin aspart) PL GB 04668/0369 (not implemented on packs yet), EU/1/99/119/020

Active Pharmaceutical Ingredient: insulin aspart

Saxenda FlexTouch (liraglutide) 6mg/ml Solution for injection in pre-filled pen PL GB 04668/0409, EU/1/15/992/003

Active Pharmaceutical Ingredient: liraglutide

Brief description of the problem

Novo Nordisk Limited would like to notify you of a defect that affects specific batches of NovoRapid FlexTouch prefilled pen device and batches of Saxenda FlexTouch prefilled pen device in the UK.

The defect results in a non-functioning device where it is not possible to set a dose because the dose selector will spin freely, as such, click sounds will not be heard. Since a dose cannot be selected, the patient cannot inject a dose. A very small number of pens are affected the average number of affected products is 2-3 pens per million pens. Based on the critical need for the products, they are not being recalled.

Advice for healthcare professionals

This information relates to both NovoRapid and Saxenda FlexTouch pens. If the pen is faulty, it will not be possible to set a dose because the dose selector will spin freely, as such, click sounds will not be heard. Since a dose cannot be selected, the patient cannot inject a dose therefore the fault will be noticeable to the patient.

• If a patient returns a faulty pen from these batches to their pharmacy or other healthcare professional, Novo Nordisk request that the healthcare professional follows the usual safety and complaints process whereby they provide the patient with a replacement pen.
  • The healthcare professional should then contact Novo Nordisk Customer Care to report it and obtain a pre-paid jiffy bag in order to return the faulty pen to Novo Nordisk who will credit the healthcare professional via their Alliance Healthcare (wholesaler) account.
• Patients are advised to always carry a spare pen to avoid any doses being missed. The pens with the affected defect are not being recalled. Patients can continue to use pens from these batches if not affected by the defect.

Advice for patients

Patients can continue to use pens from these batches; this is because only a small number of pens are affected by the defect. The defect means that some pens will not work. The defect results in a non-functioning device where it is not possible to set a dose because the dose selector will spin freely, as such, click sounds will not be heard. Since a dose cannot be selected, the patient cannot inject a dose.

If patients receive a defective pen, they should contact their healthcare professional to obtain a new supply. Patients are advised to always carry a spare pen to avoid any doses being missed.

• NovoRapid: If you miss a dose of this medicine, your blood sugar may become high. You should use a replacement pen to administer a dose as soon as possible. In the meantime, monitor your blood sugar levels more often than usual. Contact your healthcare professional if you have any concerns.
• Saxenda: If you miss a dose due to a defective pen you should obtain a replacement. If there is more than 12 hours until your next scheduled dose, then take it soon as possible. If there is less than 12 hours until your next usual dose, do not take the missed dose and resume your once-daily regimen with the next scheduled dose. An extra dose or increase in dose should not be taken to make up for the missed dose. Contact your healthcare professional if you have any concerns.

Further Information

For medical information and stock control queries please contact: Customer Care contact details+44 (0)800 023 2573 or CustomerCare@novonordisk.com

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

Class 4 Medicines Defect Information: Novo Nordisk Limited, NovoRapid FlexTouch 100 units/ml, Saxenda FlexTouch (liraglutide) 6mg/ml, EL(22)A/33