Novo Nordisk Inc initiated a recall of Levemir FlexTouch (insulin detemir) injection samples on March 22, 2021. The recall, identified as D-0614-2021, is classified as Class I by the FDA.
According to the recall record, the reason cited is temperature abuse. Product samples were stored at temperatures below 32 degrees Fahrenheit, which did not comply with required storage conditions. The recall notice states this could result in a lack of efficacy and could damage the cartridge and pen-injectors.
The affected product is Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), in a 3 mL prefilled pen sample, labeled Rx Only. It was manufactured by Novo Nordisk A/S in Bagsvaerd, Denmark, and distributed by Novo Nordisk Inc in Plainsboro, New Jersey. The listed NDC numbers are 0169-6438-90 for the pen and 0169-6438-98 for the kit.
The recall status is listed as terminated. This brief reports only the details provided in the recall record and does not characterize the overall safety profile of insulin detemir. Readers can consult the compound overview for additional context on insulin detemir.