On March 22, 2021, Novo Nordisk Inc initiated a Class I recall of FIASP FlexTouch (insulin aspart injection) sample pens. The recall covers 100 units/mL, 3 mL prefilled pen samples not for resale, identified by NDC 0169-3204-90 and NDC 0169-3204-97.
The FDA classified this recall as Class I. The reason given was temperature abuse, meaning product samples were stored at temperatures below 32 degrees Fahrenheit. This storage condition did not meet the product's requirements. According to the recall record, this could cause a lack of efficacy and damage to the cartridge and pen-injectors.
The recall was carried out by Novo Nordisk Inc, the manufacturer, based in Bagsvaerd, Denmark, with distribution handled by Novo Nordisk Inc in Plainsboro, New Jersey. The recall status is listed as terminated.
This recall pertains specifically to sample units affected by improper cold storage and reflects a classification and reason as documented in FDA recall records. Readers seeking general background on insulin aspart can consult the compound overview for additional context.</body_markdown>
<parameter name="sources">["https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts"]