Novo Nordisk Inc initiated a recall of TRESIBA (insulin degludec injection) 100 units/mL, U-100, on March 22, 2021. The U.S. FDA classified this action as a Class I recall, identified as D-0620-2021.
The affected product was a 10 mL multi-dose vial sample, not for resale, distributed under NDC 0169-2662-90. According to the recall notice, product samples were stored at temperatures below 32 degrees Fahrenheit, which does not comply with required storage conditions.
The reason cited for the recall is temperature abuse, which the notice states could cause a lack of efficacy and could damage the cartridge and pen-injectors. The recall record identifies this as a Class I classification, the FDA's designation for the most serious recall category.
The recall status is listed as terminated. This recall pertains specifically to sample product that experienced improper cold storage, not to all TRESIBA product on the market.
Insulin degludec remains an approved product. Readers seeking more background on insulin degludec, including its approved uses and general information, can consult the compound overview for additional context.</body_markdown>
<parameter name="sources">["https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts"]