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Novo Nordisk has issued an urgent product defect alert affecting the 3mL glass cartridges that contain Actrapid, NovoRapid, NovoMix 30, Mixtard 30/70, and Protaphane.

In its letter to healthcare professionals today, Novo Nordisk states that during manufacture, 'circular non-penetrating cracks on the outer surface around 4–6 mm below the ''shoulder'' of the glass cartridge were found'.

'These outer surface cracks do not compromise the integrity of the cartridge,' the statement reads.

'As the integrity of the cartridge remains intact, there is no risk of evaporation or contamination of the product.'

Novo Nordisk states that if the cartridge cracks while being handled, the product will leak and be detectable.

'The pen will not work if the cartridge is cracked,' the supplier said.

'The manufacturing root cause that created this issue has been identified and resolved.'

Novo Nordisk consulted with the Therapeutic Goods Administration, which assessed the product issue as a class 2 risk: a situation in which the use of or exposure to the deficient therapeutic good(s) may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Novo Nordisk states that the alert is a potential product manufacturing issue and not a product recall.

Recommended actions

• Where possible, pharmacists should inspect cartridges before dispensing and if defects are found, return the cartridges to the wholesaler for replacement.
• People can continue taking their medication as normal unless they observe a crack in, or of, the glass cartridge. People should not use the product and may return it for a replacement.
• Ensure relevant staff members are informed of this communication.
• Place the full Novo Nordisk letter in a prominent position for at least one month.