HPS Pharmacies wish to give notice that Novo Nordisk, in consultation with the Therapeutic Goods Administration (TGA), has issued an urgent product defect alert for multiple batches of the following insulin products:

Product Presentation ARTG
Actrapid® Penfill 169623
NovoMix® 30 Flexpen 143166
Mixtard® 30/70 Penfill 169629
Novorapid® Flexpen 133445
Novorapid® Penfill 133444
Protaphane® Penfill 169635

The defect alert was initiated following the discovery of a circumferential crack below the “shoulder” of cartridges received from one supplier. These cracks are superficial and do not compromise the integrity of the cartridge. Therefore, they do not pose a risk of contamination or evaporation of the product. However, if the cartridge cracks while being handled, the product will leak and the pen will not work. To date, Novo Nordisk has not received any customer complaints regarding this issue.

Novo Nordisk advises healthcare professionals to inspect the cartridges prior to dispensing to the patient. If defect product is found, it may be returned to the wholesaler for replacement. Patients should not use any product with a crack in the glass cartridge.

Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier, and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Novo Nordisk on 1800 668 626 or your pharmacist at HPS Pharmacies.

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