The FDA has notified patients and healthcare professionals that some stolen vials of the long-acting insulin Levemir, made by Novo Nordisk, and being sold in the U.S. market, may not have been stored and handled properly and may be dangerous for patients.
The Bagsværd, Denmark-based Novo Nordisk said its product previously reported as stolen in North Carolina has resurfaced recently at a medical center in Houston. Three lots of 10 ml vials of insulin, marketed under the brand name Levemir (insulin detemir [rDNA origin] injection), were taken in the original theft and identifiable by the following lot numbers: XZF0036, XZF0037 XZF0038.
The company said that insulin from these lots "did not circulate through the normal Novo Nordisk distribution channel and therefore proper storage conditions for the insulin may not have been followed."
Cardiologists should help identify any patients who may be using these products. The FDA advised patients who use Levemir insulin to:
- Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037 and XZF0038.
- Do not use Levemir insulin if it is from one of these lots.
- Always visually inspect the insulin before using it, as Levemir should be a clear and colorless solution.
- Contact the Novo Nordisk Customer Care Center at 800.727.6500 for what to do with vials from these lots, or with any other questions.
Levemir is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal insulin for the control of hyperglycemia.