Novo Nordisk Pharmaceuticals Pty Ltd is recalling certain batches of GlucaGen® HypoKit due to a small number of needles becoming detached from the pre-filled syringe supplied in the GlucaGen® HypoKit.
Novo Nordisk Pharmaceuticals Pty Ltd is recalling 4 batches of GlucaGen® HypoKit in Australia. GlucaGen® HypoKit is used for the ‘treatment of severe hypoglycaemic reactions which may occur in the management of diabetic patients receiving insulin or oral hypoglycaemic agents’.
This action has been undertaken following consultation with the Therapeutic Goods Administration (TGA).
Novo Nordisk conducted an investigation showing a small number (0.006%) of needles from certain batches may become detached from the pre-filled syringe supplied, during use. Despite the very low risk to patient safety, Novo Nordisk is recalling all products in the affected batches from wholesalers, pharmacies and patients in Australia.
The recalled GlucaGen® HypoKit batch numbers and expiry date in Australia are:
|Batch Number||Expiry date|
Note that community and hospital pharmacies will also be contacted and requested to follow up with patients they have supplied since February 2016 and will be asked to return any stock they hold from affected batches. Formal notification has also been sent to mainstream national media, professional diabetes/endocrine societies, RACGP, RACP and diabetes patient associations.
We have attached a patient information leaflet you may find useful when explaining to patients the nature of the issue. You may wish to share this with patients.
If patients have a GlucaGen® HypoKit from an affected batch they are to return it to their pharmacy. They will be given a free replacement either immediately (if the pharmacy has unaffected stock available) or within a few days (if the pharmacy has to await resupply). If the pharmacy does not receive a replacement immediately, the patient is to retain their GlucaGen® HypoKit until the replacement can be provided, as the likelihood of a detached needle is very low.
Importantly, if you are in possession of GlucaGen® HypoKit products with batch numbers NOT mentioned above there is NO concern and you can be confident that the products will work as prescribed.