Novo Nordisk is voluntarily recalling 1,468 product samples of its insulins, including detemir (Levemir), in the framework of (Novologist), and degludec (Tresiba) in the USA.
The recall is due to storage below the required temperature. It only concerns product samples, not products sold in pharmacies or by mail order to patients.
Storage below 32 Â° F can cause ineffectiveness and damage the cartridges and injectors of the pen. The company has not received any reports of serious adverse events related to the recall.
The products are packaged in cartons containing a vial, a pen-injector (Flexpen or FlexTouch) or a cartridge (PenFill). A full list is available here.
The product can be identified by matching the lot or lot number on the packaging to those on the list.
Novo Nordisk requests that all physician offices that received the recalled samples return them.
Patients who have received samples at their doctor’s office should receive a letter from their doctor.
The cost of insulin in the United States is known to be prohibitive; it is estimated that one in four patients with insulin-dependent diabetes uses insulin because of the cost, and people often use the samples provided to them free of charge by their doctors.
Adverse events associated with these products should be reported to the Novo Nordisk Customer Service Center at 1-800-727-6500, Monday to Friday, 8:30 a.m. to 6:00 p.m. EDT, and reported to the United States Food and Drug Administration’s MedWatch Adverse Event Reporting Program, online, by mail, or by fax.
Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work published in The Washington Post, NPR Shots Blog, and Diabetes Forecast Magazine. She’s on Twitter @MiriamETucker.