Novo Nordisk Inc initiated a recall of Fiasp PenFill (insulin aspart injection) on March 22, 2021. The U.S. Food and Drug Administration classified this action as a Class I recall.
The recalled product is Fiasp PenFill, 100 units/mL (U-100), supplied in 3 mL cartridges with 5 cartridges per package. These were sample units, not for resale, and Rx only. The NDC for the affected product is 0169-3205-91. Novo Nordisk A/S, based in Bagsvaerd, Denmark, manufactured the product.
According to the recall record, the reason cited was temperature abuse. Product samples were stored at temperatures below 32 degrees Fahrenheit, which did not meet required storage conditions. The recall documentation states this could cause a lack of efficacy and could damage the cartridge and pen injectors.
The recall status is listed as terminated. The FDA recall identifier for this action is D-0612-2021.
This brief reports only the details contained in the recall record. It does not characterize the clinical significance of the storage issue beyond what the record states. Readers can consult the compound overview for additional context on insulin aspart.</body_markdown>
<parameter name="sources">["https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts"]