GlucaGen HypoKit Recall

NOVO Nordisk has alerted pharmacists about the recall of four batches of its GlucaGen HypoKit in Australia, after an investigation found a small number of needles were detached from the pre-filled syringes in the products.

The kit is indicated for the “treatment of severe hypoglcaemic reactions (low blood sugar) which may occur in the management of diabetic patients receiving insulin or oral hypglycaemic agents’.  “To protect patient safety Novo Nordisk is recalling affected batches from wholesalers, pharmacies and patients in Australia,” the firm said.

The affected batch numbers are;

• FS6X465
• FS6X536
• FS6X715
• FS6X891

- all with an expiry date of 31 Aug 2017.

Patients or carers are urged to check the batch number (pictured in the red box) of any GlucaGen HypoKits in their possession.

Affected items should be returned to the pharmacy where it was purchased, where a replacement will be supplied at no charge.  If the pharmacy is out of stock patients are being told to retain the kit until a replacement can be provided “as the likelihood of a detached needle is very low”.

“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  careprofessionals,” the company said.  “We are working closely with the Therapeutic Goods Administration to ensure patient safety and minimise the disruption this recall causes,” Novo Nordisk added.

The problem appears to be a global issue for Novo Nordisk, with the company also the subject of a UK medicines and Healthcare products Regulatory Agency patient level drug recall of eight batches of the GlucaGen HypoKit in Britain with various expiry dates in 2018.

Source: PharmacyDaily, Thursday 8 September 2016