Novo Nordisk Inc initiated a Class I recall of NovoLog FlexPen (insulin aspart) on March 22, 2021. The recall covers NovoLog FlexPen Injection, 100 units/mL, 3 mL prefilled insulin syringe pen samples, marked not for resale and Rx only. The affected NDC numbers are 0169-6339-90 for the pen and 0169-6339-98 for the kit.
The reason given for the recall is temperature abuse. According to the event record, product samples were stored at temperatures below 32 degrees Fahrenheit, which does not comply with required storage conditions. The recall notice states this could cause a lack of efficacy and physical damage to the cartridge and pen injectors.
The FDA classified this action as Class I, the agency's highest classification level. The recall status is listed as terminated. This recall pertains specifically to sample units of NovoLog FlexPen and was recorded under FDA recall identifier D-0615-2021.
This report reflects only the details contained in the recall record, including the classification, reason, firm, and dates as stated. Readers can consult the compound overview for additional context on insulin aspart.