Product Defect Alert

HPS Pharmacies wish to advise that Novo Nordisk, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect alert for the following insulins:

NovoRapid® Flexpen
Insulin Aspart 300U/3mL
ARTG 133445

NovoMix® 30 Penfill
Soluble insulin aspart 30% + insulin aspart 70% 300U/3mL
ARTG 143165

Fiasp® Flextouch
Insulin Aspart 300U/3mL
ARTG 275394

This product defect alert is in regards to text errors in the pack inserts of all batches of NovoRapid® FlexPen, Fiasp® FlexTouch and NovoMix® 30 Penfill supplied in Australia since June 2021.

The pack insert for NovoRapid® FlexPen and Fiasp® FlexTouch incorrectly states the storage requirements, while the pack insert for NovoMix® 30 Penfill contains an incomplete description of an active ingredient and its appearance. However, this information is correct on the product cartons and the Product Information documents. No adverse events associated with this issue have been reported to NovoNordisk to date.

Actions proposed by NovoNordisk:

  • Advise patients to follow the instructions written on the carton for in-use storage details;
  • Counsel patients about the error when dispensing affected products; and
  • Provide a current copy of the Consumer Medicine Information from the TGA website.

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 NovoNordisk on 1800 668 626 or your pharmacist at HPS Pharmacies.

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