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  • Drug Safety Update includes eluxadoline, fingolimod

    Drug Safety Update includes eluxadoline, fingolimod

    Tuesday, 19 December 2017 10:16
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    MHRA issues new batch of Drug Safety Update notices

    Tuesday, 28 November 2017 09:52
  • Vitamin D intake guidance for pregnant mums and babies updated in Scotland

    Vitamin D intake guidance for pregnant mums and babies updated in Scotland

    Monday, 27 November 2017 14:50
  • Numbers of people with heart failure diagnoses is up 23% since 2002

    Numbers of people with heart failure diagnoses is up 23% since 2002

    Friday, 24 November 2017 13:06

A Resized Recall Image cb1August 24 2017

A recall affecting 53 batches of Novo Nordisk’s NovoPen Echo and 34 batches of NovoPen 5 insulin pens has been issued. The recall is due to cracked or broken insulin cartridge holders.

 The MHRA is advising health professionals to identify patients who may have been supplied with either brand of product and ask them to check the batch number against the list which is contained on the manufacturer’s field safety notice.

Patients can also contact Novo Nordisk directly on the Customer Care line on 0845 600 5055 or use the manufacturer’s website to check if their device is affected and to request a replacement cartridge holder, says the MHRA alert.

For patients affected by the recall, check whether they are able to maintain their insulin regime via a suitable device or alternative method.

Any affected stock held in dispensaries should be quarantined. Contact Alloga on 01773 515124 to arrange replacements and return affected stock.

The MHRA alert explains the nature of the fault: “In July 2014, a redesigned cartridge holder for NovoPen Echo and NovoPen 5 was implemented to improve robustness. However, the redesigned cartridge holder can become weakened if it is exposed to chemicals in cleaning agents, sunscreen and food grease, and the snaps keeping the cartridge holder in place may crack or break off.

“There are 3 types of fault that can occur:

  • ‘Snap cracked’
  • ‘One snap broken off’
  • ‘Both snaps broken off’

“In April 2016 Novo Nordisk decided to change production back to the original cartridge holder so that in future all products would be produced with the original cartridge holder. This was effective from 1 September 2016.”

Links:
MHRA alert         
Manufacturer’s Field Safety Notice listing affected batch numbers          

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