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.
Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.
The FDA (U.S. Food and Drug Administration) has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots.
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, and XZF0038. Patients 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 healthcare provider as another insulin product may require adjustments in dosing.
3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.
4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have 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 (long-acting) insulin for the control of hyperglycemia.
Source: U.S. Food and Drug Administration, USA