The UK medicines safety regulator has asked patients with diabetes to check whether they have certain batches of GlucaGen HypoKits after a fault was identified with the kits’ needles.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a patient level recall of the affected kits, which are used for the emergency treatment of severe hypoglycaemia. The fault means that some needles have detached from the syringe in the kits, rendering them unusable.
Affected batches should not be used, the MHRA says, because a delay in treatment could have severe health consequences in an emergency situation.
Novo Nordisk, the manufacturer of the kits, discovered that 0.006% of needles have detached from the syringe in the GlucaGen HypoKit.
“Whilst only a small number of these kits are affected by this fault, it is important that people are confident their treatment will be effective in the event of emergency,” says Gerald Heddell, the MHRA’s director of inspection, enforcement and standards. “People with these kits should check which batch their kit is from and, where necessary, get a replacement from a pharmacist.”.
The affected batches are FS6W939, FS6X059, FS6X196, FS6X590, FS6X717, FS6X899 and FS6Y024, which have expiry dates ranging from 31 May 2018 to 30 September 2018 and were first distributed between 26 February 2016 and 6 May 2016.