On March 22, 2021, Novo Nordisk Inc initiated a Class I recall of TRESIBA FlexTouch (insulin degludec injection) 200 units/mL, 3 mL prefilled pen samples. The recall involved product identified as NDC 0169-2550-90 (Pen) and 0169-2550-97 (Kit).
According to the recall record, the reason was temperature abuse. Product samples were stored at temperatures below 32 degrees Fahrenheit, which does not comply with required storage conditions. The recall notice states this storage deviation could cause a lack of efficacy and damage to the cartridge and pen-injectors.
The FDA classified this action as Class I. TRESIBA FlexTouch is manufactured by Novo Nordisk A/S in Bagsvaerd, Denmark, and distributed by Novo Nordisk Inc in Plainsboro, NJ. The recall status is listed as terminated.
This recall pertains specifically to the sample product noted above and the temperature storage issue described in the record. No additional details beyond the classification, reason, firm, and dates were provided in the recall record.
Readers can consult the compound overview for further context on insulin degludec.</body_markdown>
<parameter name="sources">["https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts"]