Novo Nordisk is voluntarily recalling 1468 product samples of its insulins including detemir (Levemir), aspart (Novolog), and degludec (Tresiba) in the US.
The recall is due to storage below the required temperature. It only affects product samples, not the products sold in pharmacies or by mail-order services to patients.
Storage below 32ºF could lead to lack of efficacy and damage to pen cartridges and injectors. The company has not received any reports of serious adverse events related to the recall.
The products are packaged in cartons containing a vial, pen-injector (Flexpen or FlexTouch), or cartridge (PenFill). A complete list is available here.
The product can be identified by matching the batch or lot number on the package to those on the list.
Novo Nordisk requests that all physician offices that received the recalled samples return them.
Patients who were given samples at their physician’s office should receive a letter from their physician.
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 ration insulin because of cost, and people often use samples given to them for free by their doctors.
Adverse events associated with these products should be reported to Novo Nordisk’s Customer Care Center at 1-800-727-6500, Monday through Friday, 8:30 AM to 6:00 PM EDT, and reported to the US Food and Drug Administration’s MedWatch Adverse Event Reporting program either 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 appearing in the Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She is on Twitter @MiriamETucker.
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