Novo Nordisk Inc initiated a recall of Fiasp (insulin aspart injection), 100 units/mL, on March 22, 2021. The recall was classified as Class I by the FDA. The affected product was a sample, not for resale, packaged as a 10 mL multi-dose vial under NDC 0169-3201-90. The stated reason for the recall was temperature abuse. Product samples were stored at temperatures below 32 degrees Fahrenheit, which does not conform to required storage conditions. According to the recall notice, this storage condition could cause a lack of efficacy and could damage the cartridge and pen-injectors. The recall record identifies the firm responsible as Novo Nordisk Inc, based in Bagsvaerd, Denmark. The FDA recall status for this action is listed as terminated. The recall record is identified with the number D-0613-2021. This report reflects only the information contained in the FDA recall record and does not include additional details about distribution scope or patient impact. Readers seeking general background on insulin aspart, including its approved regulatory status, can consult the compound overview for further context.
Fiasp (insulin aspart) Class I Recall Initiated by Novo Nordisk
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Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts