Novo Nordisk Inc initiated a recall of TRESIBA FlexTouch (insulin degludec injection) 100 units/mL, 3 mL prefilled pen samples on March 22, 2021. The recall is classified as Class I by the FDA. The stated reason is temperature abuse, meaning product samples were stored at temperatures below 32 degrees Fahrenheit, which does not meet required storage conditions. According to the recall record, this deviation could cause a lack of efficacy and damage to the cartridge and pen-injectors. The affected product is identified as TRESIBA FlexTouch, manufactured by Novo Nordisk A/S in Bagsvaerd, Denmark, and distributed in the United States by Novo Nordisk Inc, Plainsboro, New Jersey. The recall record lists NDC numbers 0169-2660-90 for the pen and 0169-2660-97 for the kit, and notes the product is a prescription-only sample. The recall event, identified as D-0619-2021, has a status of Terminated according to the FDA record. This report reflects only the details contained in the recall notice and does not characterize the overall safety of insulin degludec beyond this specific action. Readers can consult the compound overview for additional context on insulin degludec.
TRESIBA (Insulin Degludec) Class I Recall Initiated March 2021
See the full insulin degludec overview
Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts