Recall of Four Batches of GlucaGen HypoKit to Patient Level in Ireland

Notice type: Recall

Date: 06/09/2016


Product name or type:
GlucaGen HypoKit 1 mg Powder and Solvent for Solution for Injection


Authorisation Number:
PA218/31/2 & PPA465/331/1

Active Substance:
Glucagon Hydrochloride

Product Classification:
Prescription-only medicine

Serial Or Batch Number And Expiry Date:

Marketing Authorisation No.

Marketing Authorisation Holder

Batch No.

Expiry date


Novo Nordisk






PCO Manufacturing

FS6X718  / PC: 206


FS6X718 / PC: 208


These batches were first distributed in Ireland on 11th March 2016

Prescription Required:

Recall Classification:
Wholesale, Pharmacy and Patient Level

Target Audience:
Patients / Carers, Pharmacists and other relevant Healthcare Professionals and Wholesalers

Problem Or Issue:
The Health Products Regulatory Authority wishes to advise that four batches of the product GlucaGen HypoKit 1mg are being recalled to patient level in Ireland. 

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%) the syringe needle has become detached from the syringe.  Units with a detached needle cannot be used to prepare the medicine for administration.

Actions To Be Taken:

Information for Patients / Carers:

  • Please check the batch number on the units currently in your possession.


For PA218/31/2, the batch number is found in the red box, as indicated below


recall 4

For PPA465/331/1, the batch number (which includes both BN and PC numbers) is found in the red boxes, as indicated below

recall 5


  • If you are in possession of a pack from any of the four batches listed above, please return it to your pharmacy where you will receive a replacement, unaffected pack
  • If you are in possession of Glucagen Hypokit with a batch number not mentioned above, you do not need to return the unit to your pharmacy


Specific Information for Pharmacists and other Healthcare Professionals:

  • Please immediately quarantine any units of any of the above-listed batches which you have in your possession. For hospital pharmacies, this includes wards, clinics, units at paramedic level and any other relevant locations within your facility.


  • Quarantined units will be uplifted by Allphar Services Ltd and / or PCO Manufacturing


  • We are requesting that packs from the above-listed batches are recalled from patients, so please perform the following actions:
  • Please check your dispensing records to identify patients to whom the product has been dispensed, from 11th March 2016 to date. Please note that 11th March 2016 is the date on which the impacted batches were first distributed to pharmacies


  • Please endeavour to contact those patients by telephone, to ascertain if they have any remaining unused units from the affected batches. If units are identified by patients, please request that they return the units to you at their earliest opportunity, for replacement.


  • Replacement unaffected batches are available to order through normal wholesaler ordering.This should be done as a priority so that unaffected units are available to provide to patients, should they return their product to you.


  • Please quarantine any packs that are returned to you by patients ensuring that replacement unaffected packs are available to dispense to patients upon return of units that are subject to the recall


Specific Information for Wholesalers:

  • Please immediately quarantine any units from the above referenced batches which you have in your possession.

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