NABP Special e-News Alert: June 15, 2009

June 15, 2009 12:00 am

URGENT — Special e-News Alert:

FDA Urges Pharmacies, Wholesalers to Stop Dispensing, Distributing Insulin Product, as Improper Product Storage Poses Patient Safety Risk

Stolen Insulin Vials Resurface in US Market

Stolen vials of the long-acting insulin Levemir^® made by Novo Nordisk Inc have reappeared and are being sold in the United States market, Food and Drug Administration (FDA) reported on June 13, 2009. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.

Three lots of 10 ml vials (a total of 129,000 vials) of the product, insulin detemir (rDNA origin) injection, were originally reported stolen in North Carolina and are identifiable by the following lot numbers:

• XZF0036
• XZF0037
• XZF0038

FDA 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.

FDA urges pharmacies and wholesalers to check their inventories for these lot numbers of Levemir insulin products and to stop distributing or dispensing the Levemir. FDA asks pharmacies and wholesalers to contact the FDA Office of Criminal Investigations online or by phone at 800/551-3989 if they have any vials with the affected lot numbers in stock, or if patients return any of these vials. FDA asks distributors and dispensers to retain any such vials, and not to dispose of any of them.

If pharmacies are able determine if Levemir insulin vials with these lot numbers were dispensed to patients, FDA advises them to contact those patients and ask them to return the vials to the pharmacy.

FDA requests that the boards of pharmacy promptly share this information with their licensees.

More information is available in the June 13, 2009 FDA news release or from Novo Nordisk at 1-800-727-6500.