Published: 9 September 2016
Revised: 29 August 2023
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.
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
| Online |
Submit a CARM report Prescribers can also submit a report using the online reporting tool available in patient management software. |
| CARMReport@health.govt.nz |
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.
