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Safety Information

Trans-Tasman Early Warning System — Alert Communication

Consumer Level Recall – GlucaGen® HypoKit 1 mg solution for injection

9 September 2016

Products Affected
Information for consumers and caregivers
Information for healthcare professionals
What action is Medsafe taking?
How to report adverse events

Description

Medsafe has been notified that a small number (0.006%) of GlucaGen® HypoKit needles may become detached from the pre-filled syringe supplied, during use. Following consultation with Medsafe, Novo Nordisk Pharmaceuticals Ltd is recalling two batches of GlucaGen® HypoKit (batch numbers FS6X537 and FS6X873) from the New Zealand market.

Products Affected

The product is: GlucaGen® HypoKit 1 mg solution for injection
Batch Numbers: FS6X537 and FS6X873



Information for consumers and caregivers

  • Please check the batch number on your GlucaGen® HypoKit. If you are in possession of a GlucaGen® HypoKit with the batch number FS6X537 or FS6X873, please return it to your pharmacy and you will be given a free replacement.
  • If you do not receive a replacement immediately, retain your GlucaGen® HypoKit until the replacement can be provided, as the likelihood of a detached needle is very low.
  • If you are in possession of a GlucaGen® HypoKit product with a batch number NOT mentioned above there is NO concern and you can be confident that the product will work as intended.

Where to find the batch number

 

Information for healthcare professionals

  • This recall only applies to GlucaGen® HypoKit from batches FS6X537 and FS6X873.
  • Replacement stock of an unaffected batch is available. Please obtain this from your usual supplier so that you can replace recalled stock as it is returned to you.
  • In the event that you do NOT have stock from unaffected batches when a patient presents, please advise the patient to retain their current GlucaGen® HypoKit from the affected batch until a replacement can be provided, as the likelihood of a detached needle is very low.

What action is Medsafe taking?

A consumer level recall of GlucaGen® HypoKit with the batch numbers FS6X537 or FS6X873.

 

How to report adverse events

Phone + 64 3 479 7247 to speak to a Medical Assessor at the Centre for Adverse Reactions Monitoring (CARM)
Online Submit a report to CARM
Prescribers can submit using the online reporting tool available in patient management software
Email carmnz@otago.ac.nz
Fax +64 3 479 7150


Medsafe cannot give advice about an individual's medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

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