Novo Nordisk voluntarily recovers 1468 product samples from its insulins, including detemir (Levemir), as part (Novolog), and degludec (Tresiba) in the US.
Withdrawal is due to storage below the required temperature. It only affects product samples, not products sold in pharmacies or by mail order services to patients.
Storage below 32ºF can cause inefficiency and damage pen cartridges and injectors. The company has not received any reports of serious adverse events related to the withdrawal.
The products are packaged in cardboard boxes 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 batch or batch number of the package with those in the list.
Novo Nordisk requests that all medical offices that received the withdrawn samples return them.
Patients who received samples at the doctor’s office should receive a letter from their doctor.
The cost of insulin in the United States it is known to be prohibitive; it is estimated that one in four patients with diabetes-dependent insulin ration due to cost, and people often use samples that their doctors give them for free.
Adverse events associated with these products should be reported to the Novo Nordisk Customer Service Center at 1-800-727-6500, Monday through Friday, 8:30 a.m. to 6:00 p.m. EDT, and reported to the U.S. Food and Drug Administration’s MedWatch Adverse Event Information 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.