Novo Nordisk said in a press release Monday that it would recall a number of batches of its ClucaGen HypoKit worldwide.

"Novo Nordisk has conducted an investigation which found that a small percentage (0.006%) of needles have detached from the syringe in certain batches of the GlucaGen HypoKit. Out of consideration for patient safety, Novo Nordisk is recalling the affected batches from distributors, pharmacies, and patients in Denmark and other affected countries,” the company says in the press release.

The company informs MedWatch that 750 units of the product is affected in Denmark. Moreover, Orifarm and Paranova parallel import the product, but Novo Nordisk is not aware how many products these companies have sold. In total, 55 batches – or 363,000 units - of the product are affected by the global recall which covers 31 countries.

GlucaGen HypoKit is used for the emergency treatment of severe low blood glucose (hypoglycaemia) in diabetes patients, when they are unconscious or unable to consume sugar. It is very important to have this emergency kit on hand, the company says.

“Novo Nordisk is committed to delivering high quality products. We deeply regret this unfortunate situation and the concern and trouble it causes for patients and healthcare professionals. Novo Nordisk is working closely with health authorities to ensure patient safety and to minimize the disadvantages of the recall,” the company writes in the press release.

The substance GlucaGen was approved in 1998, while the GlucaGen HypoKit was launched in the US in 2005.

It is not the first time Novo Nordisk has been forced to recall the product. Issues arose in 2010 when some of the glass vials containing the powder for injection in the affected batch had been cracked or broken during the manufacturing process.

It could render the product useless and the Danish Medicines Agency demanded that the affected products be pulled from the market. The recall was later extended to include products in New Zealand and Canada as well.

And in January this year, a batch of HypoKits was recalled in Switzerland after the company had found traces of stainless steel particles on the rubber plunger of the syringe.

 Lars Rebien steps down as CEO of Novo Nordisk 

 Novo Nordisk imposes hiring freeze in Denmark 

- translated by Martin Havtorn Petersen

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