FDA issues health advisory regarding stolen insulin vials

posted on:
June 14, 2009

author:
JENNIFER WALKER-JOURNEY

A batch of insulin stolen from North Carolina has turned up at a medical center in Houston and the Food and Drug Administration (FDA) is warning that patients and health care providers not use the product for fear it may be contaminated.

In a Health Advisory issued this weekend, the FDA says that some vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have resurfaced from three lots, or a total of 129,000 vials, that had been stolen. The vials may not have been stored or handled properly and may be dangerous for patients to use. The FDA already has received one report of a patient who suffered an adverse reaction due to poor control of glucose levels after using a vial that was traced back to the stolen lots.

The FDA is advising patients who use Levemir insulin to check their supply of the medication to determine if they have vials from the affected lots. The lot numbers can be found on the side of the box as well as the side of the bottle. The affected lots are XZF0036, XZF0037, and XZF0038.

If patients find vials with the above-mentioned lot numbers in their possession, the FDA advises they replace those vials with ones that are not affected by the issue. Patients should also contact their health care provider, especially if they switch brands of insulin as another insulin product may require adjustments in dosing. They should also contact Novo Nordisk Customer Care at 800-727-6500 for advice on what to do with the vials from the affected lots.

The FDA also advises patients to inspect their supply of insulin visually before using it. Levemir is a clear and colorless solution.

Source: FDA

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