Safety Alerts & Recalls

What does this mean?

Since improper storage can affect how well Insulin Detemir works, this alert should be taken seriously. If you are using Insulin Detemir, please do the following:

1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036; XZF0037; XZF0038. You can locate the lot number on the side of the box of insulin and also on the side of the vial.

2. Do not use your Levemir insulin if it is from one of these lots. If you have Levemir insulin from one of these lots or do not know the lot number of your Levemir insulin vials, please take your vials to your pharmacy as soon as possible to examine and possibly exchange.

3. Always look at your insulin carefully before using it. Levemir is a clear and colorless solution. If you have any questions about the quality of your insulin, please follow up with your pharmacist.

4. If you think you are experiencing side effects related to your insulin, please follow up with you doctor as soon as possible.

For more information about these stolen vials, you can also contact the Novo Nordisk Customer Care Center at 1-800-727-6500. The FDA is asking for the public's help in reporting any information regarding these vials to the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989.

Reminder Alert: Three Lots of Levemir Insulin Reported Stolen

The FDA has issued an alert to remind the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. The FDA believes the stolen insulin was not stored and handled properly and may be dangerous for people to use. The FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots. Since the FDA first alerted the public to the theft in June, only about 2 percent of the total amount stolen has been recovered. Over 100,000 vials may still be on the market.

The following lots of Levemir insulin have been reported stolen and should not be used: XZF0036, XZF0037, and XZF0038.

Levemir, also called insulin detemir [rDNA origin], is a long-acting insulin used in the treatment of diabetes.

For more information, please visit: more information here

To view the June 2009 iGuard alert about these stolen vials, please visit: more information here

Source: FDA
Publication Date: 2009-08-27
Last Updated: 2009-12-05

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