Novo Nordisk is voluntarily recalling 1468 product samples of Levemir® (insulin detemir [rDNA origin]), Tresiba® (insulin degludec), Fiasp® (insulin aspart), Novolog® (insulin aspart [rDNA origin]) and Xultophy® (insulin degludec) to the consumer level due to the products being stored at temperatures below storage requirements.
Levemir, Tresiba, Fiasp, Novolog and Xultophy are used to improve glycemic control in patients with diabetes mellitus. The recall only affects product samples and does not affect products that have been distributed to pharmacies or mail order services. The full list of recalled product samples can be found here.
According to the Company, if product samples are stored at temperatures below 32°F, there may be a lack of efficacy and damage to the cartridge and pen injectors. Patients who receive an improperly stored product may not receive the right amount of medication which could potentially lead to hypoglycemia or hyperglycemia. The Company has notified all physician offices that received affected samples and requested the return of any affected product.
At this time, the Company has not received any reports of serious adverse events or injuries related to this recall. Any adverse events should be reported to the FDA’s MedWatch program.
For more information, contact Novo Nordisk at (800) 727-6500.
Novo Nordisk issues voluntary nationwide recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® product samples due to improper storage temperature conditions. [press release]. Silver Spring, MD: US Food and Drug Administration; May 10, 2021.