Novo Nordisk Inc initiated a recall of Xultophy 100/3.6 (insulin degludec and liraglutide injection) on March 22, 2021. The recall, identified as D-0623-2021, was classified as a Class I recall by the FDA. The affected product was a sample pen, NDC 0169-2911-90 and 0169-2911-97, manufactured by Novo Nordisk A/S and distributed by Novo Nordisk Inc.
The stated reason for the recall was temperature abuse. According to the event record, product samples were stored at temperatures below 32 degrees Fahrenheit, which does not meet storage requirements. The recall notice states this condition could cause a lack of efficacy and could damage the cartridge and pen injectors.
The recall status is listed as terminated. The event record does not provide additional detail beyond the classification, reason, firm, and product description listed above. No information was given regarding adverse events, patient outcomes, or further corrective actions taken by the firm.
Readers seeking general background on liraglutide, including its regulatory status and other uses, can consult the compound overview for additional context.