The Food and Drug Administration (FDA) announced that global healthcare company Novo Nordisk has voluntarily recalled samples of its insulin medication taken for diabetes, a health condition that affects over 34 million people in the United States alone.
The company recently recalled nearly 1,500 samples of Levemir®, Tresiba®, Fiasp®, NovoLog®, and Xultophy® — all insulin products that are prescribed to lower a diabetes patient’s blood glucose levels. It was also revealed that all recalled items “are packaged in cartons with either a vial, pen-injector (FlexPen® or FlexTouch®) or a cartridge (PenFill®).” The company stresses that use of a recalled product sample may not deliver the correct dosage, possibly leading to “hyperglycemia or hypoglycemia resulting in adverse health consequences ranging from limited to life-threatening.”
The samples were not stored within the correct temperature ranges, which can cause diminished product efficacy. Fierce Pharma reports that the issues occurred during the winter storm power outages in Texas earlier this year as well as due to human error in physician offices. With about 1.5 million samples in-market, this recall affects 0.1 percent of samples from Novo Nordisk.
For more information about this recall, contact us today.
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.