FDA Advisory About Levemir Insulin
On June 13, 2009, the Food and Drug Administration (FDA) issued an advisory about the long-acting insulin Levemir made by Novo Nordisk. FDA has learned that some stolen vials of Levemir have reappeared and are being sold in the U.S. market. The stolen insulin vials may not have been stored and handled properly and may be dangerous for people to use. Three lots, or a total of 129,000 vials, of the insulin were stolen.
FDA has received one report of a patient who suffered a dangerous side effect due to poor control of glucose levels after using a vial of the stolen insulin.
FDA advises people 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, or XZF0038. You can locate the lot number on the side of the box of insulin and also on the side of the vial.
- Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your health care provider because you may need a different dose of another insulin product.
- Always look at your insulin carefully before using it. Levemir is a clear and colorless solution.
- Contact the Novo Nordisk Customer Care Center at 800-727-6500 for instructions on what to do with vials from these lots or if you have any other questions.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: June 18, 2009