Patient Level Recall of GlucaGen® HypoKits Used for the Emergency Treatment of Severe Low Blood Glucose (Hypoglycaemia)

News Category: Regulatory news

Date: 06/09/2016

The Health Products Regulatory Authority (HPRA) today confirms that a patient level recall of certain batches of GlucaGen® Hypokits used for the emergency treatment of severe low blood glucose is being undertaken. It is advising patients and carers to check the batch number on any GlucaGen Hypokit units they may have at home or in their possession and to return any of the affected product to their pharmacist where a replacement will be provided.

GlucaGen HypoKit is packaged with a syringe containing sterile water for injection which is used to prepare the medicine for use. The reason for the recall is that in a small number of units (0.006% approx) the syringe needle has become detached from the syringe. Units with a detached needle cannot be used to prepare the medicine for administration.

GlucaGen Hypokits are used in emergency situations to treat severe hypoglycaemia in children and adults with diabetes mellitus. While a very small number of units are likely to be impacted, a delay in emergency treatment could have significant health consequences and, therefore, units from affected batches should not be used and should be returned to the dispensing pharmacy where a replacement will be provided.

Two batches of Novo Nordisk GlucaGen Hypokit and two batches of PCO Manufacturing GlucaGen Hypokit are being recalled in Ireland and this represents a total of 8,064 units.

The affected batch numbers, which are printed on the product label along with an expiry date, are as follows:   

Patients and carers who have a Glucagen Hypokit with a batch number which is not mentioned above, do not need to return the unit to their pharmacy.

The HPRA will closely monitor the recall and provide further updates as necessary on www.hpra.ie

How to Identify the Batch Numbers

Novo Nordisk GlucaGen Hypokits:

1. Firstly check if you have a GlucaGen Hypokit which has a marketing authorisation no. PA218/31/2.
2. If the GlucaGen Hypokit has this authorisation number, then next check the batch number to confirm if it is one of the batches being recalled. The batch number can be found on the part of the label highlighted by the red box below.
3. If the batch number is FS6X249 or FS6X592, then please contact your pharmacist to return the unit and to receive a replacement unit.

PCO Manufacturing GlucaGen HypoKits: 

1. Firstly, check if you have a GlucaGen HypoKit which has a marketing authorisation no. PPA465/331/1.
2. If the GlucaGen HypoKit has this authorisation number, then next check the batch number to confirm if it is one of the batches being recalled. The batch number (which is a combination of BN and PC numbers) can be found on the parts of the label highlighted by the red boxes below.
3. If the batch number is BN: FS6X718 / PC: 206 or BN: FS6X718 / PC: 208, then please contact your pharmacist to return the unit and receive a replacement unit.

For Further Information

Weber Shandwick PR                             (01) 679 8600

Siobhan Molloy / Barry Ryan                   086 817 5066 / 085 728 7326

ABOUT THE HEALTH PRODUCTS REGULATORY AUTHORITY

The Health Products Regulatory Authority (HPRA) protects and enhances public health and animal health by regulating medicines, medical devices and other health products. The products under its remit include human and veterinary medicines, medical devices, blood and blood components, tissues and cells, organs for transplantation and cosmetics.