Novo Nordisk is recalling 4 batches of GlucaGen® HypoKit in Australia. The GlucaGen® HypoKit is indicated for the ‘treatment of severe hypoglycaemic reactions (low blood sugar) which may occur in the management of diabetic patients receiving insulin or oral hypoglycaemic agents’.
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Novo Nordisk conducted an investigation showing a small number (0.006%) of needles were detached from the pre-filled syringe supplied in certain batches of GlucaGen® HypoKit. To protect patient safety Novo Nordisk is recalling affected batches from wholesalers, pharmacies and patients in Australia.
The recalled GlucaGen® HypoKit batch numbers and expiry dates are:
- Batch No: FS6X465, Expiry: 31-Aug-2017
- Batch No: FS6X536, Expiry: 31-Aug-2017
- Batch No: FS6X715, Expiry: 31-Aug-2017
- Batch No: FS6X891, Expiry: 31-Aug-2017
Patients or carers should check the batch number of any GlucaGen® HypoKits in their possession to see if their GlucaGen® HypoKit is affected. The batch number is printed on the GlucaGen® HypoKit as indicated below in the red box (Figure 1).
Advice to patients in possession of a GlucaGen® HypoKit with one of the above-mentioned batch numbers:
- Return your GlucaGen® HypoKit product with the above-mentioned batch numbers to your pharmacy. You will be given a free replacement GlucaGen® HypoKit either immediately (if pharmacy stock is present) or within a few days (if pharmacy needs to await re-supply). 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.
- Report any adverse drug reactions to Novo Nordisk’s customer care number, which can be reached at 1800 668 626 or via email at aunrccc@novonordisk.com
Novo Nordisk is committed to delivering high-quality products and sincerely apologises for this unfortunate situation and the concerns and inconvenience it may cause patients and health care professionals. We are working closely with Therapeutic Good Administration (TGA) to ensure patient safety and minimise the disruption this recall causes.
Importantly if patients are in possession of a GlucaGen® HypoKit with a batch number NOT mentioned above there is NO concern and they can be confident that the product will work as prescribed.
