Warning--Stolen Levemir--FDA

[We Hope]

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm166358.htm

For Immediate Release: June 13, 2009

FDA Issues Public Health Advisory Regarding Levemir Insulin

http://press.novonordisk-us.com/index.php?s=43&item=204

Novo Press Release

PRINCETON, N.J., June 13 /PRNewswire-FirstCall/ -- Novo Nordisk 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.


A vial or vials of stolen insulin from lot XZF0037 was discovered this week at a medical center in the Houston area. 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.


Patients can locate the lot number on the side of the box of insulin or the side of the vial. If a patient finds their insulin is from one of the stolen lots, they should not use the insulin and contact Novo Nordisk Customer Care Center at 1-800-727-6500 for further information and instructions.


Kathy

Note--something on the copy of the FDA notice about the stolen Levemir insulin has triggered a white list/internal server error which will not allow me to post it.

[We Hope]

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm180239.htm

FDA Warns About Stolen Insulin
Update to June Alert

The U.S. Food and Drug Administration is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market.

Evidence gathered to date suggests that 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.

When the FDA first alerted the public to the theft in June, it reported that three lots of Levemir totaling 129,000 vials had been stolen in North Carolina. So far only about 2 percent of the total amount stolen has been recovered.

The FDA continues to aggressively investigate this matter and 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 or by visiting the OCI Web site.

The agency is advising patients who use Levemir insulin to:

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. 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 another insulin product may require adjustments in dosing.

3. Always look at your insulin carefully before using it. Levemir is a clear and colorless solution.

Updating this story, as much of the improperly kept stolen Levemir still may be available on the market.