Novo Nordisk Inc initiated a recall of NovoLog (insulin aspart) on March 22, 2021. The recall is classified as Class I by the FDA. The affected product is NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), packaged as a one 10 mL multi-dose vial sample, not for resale, Rx only, with NDC 0169-7501-90. It was manufactured by Novo Nordisk A/S in Bagsvaerd, Denmark.
The stated reason for the recall is temperature abuse. Product samples were stored at temperatures below 32 degrees Fahrenheit, which does not meet the required storage conditions. The event record states this could cause a lack of efficacy and damage to the cartridge and pen-injectors.
The recall status is listed as terminated. The recall identifier associated with this action is D-0616-2021. This information reflects the recall record as reported and does not include additional findings beyond what is stated.
Readers seeking more background on insulin aspart can consult the compound overview for further context.