MHRA Class 4 Medicines Defect Information: NovoRapid FlexTouch 100units/ml and Saxenda FlexTouch 6mg/ml

Class 4 Medicines Defect Information:

NovoRapid® FlexTouch® 100 units/ml and Saxenda® FlexTouch® (liraglutide) 6mg/ml (Novo Nordisk Limited)

Drug alert number: EL (22)A/33

Date issued: 21 July 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Novorapid FlexTouch 100units/ml solution for injection in pre-filled pen (insulin aspart) PL GB 04668/0369

Active Pharmaceutical Ingredient: insulin aspart

Saxenda FlexTouch (liraglutide) 6mg/ml solution for injection in pre-filled pen PL GB 04668/0409

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.

View full alert here

Further Information

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