May 7, 2021
NovoNordisk has voluntarily recalled 1,468 samples of the following insulin products: Levemir®, Tresiba®, Fiasp®, Novolog®, and Xultophy®. The affected samples were stored at temperatures below storage requirements. The products were exposed to temperatures below 32°F, which could cause a lack of efficacy and damage to the cartridges and pen-injectors.
The affected insulin products are used to help lower blood glucose levels in patients who have diabetes. They are packaged in cartons with a vial, pen-injector (FlexPen® or FlexTouch®), or a cartridge (PenFill®). If an improperly stored vial, cartridge, or pen-injector is used, there is a risk the patient may not receive the right amount of medication. This could lead to hyper- or hypoglycemia, which could cause adverse events ranging from mild to life-threatening in severity. Novo Nordisk had not received any reports of serious adverse events or injuries related to affected products as of the date of the recall.
Novo Nordisk has notified all physician offices that received the recalled samples and has asked that the samples be returned. According to the recall announcement, individuals who received a recalled sample through a physician’s office should have received a letter from the office. Affected samples can be identified by the batch or lot number located on the product or carton. A list of recalled batch and lot numbers has been provided in the recall notice posted on the U.S. FDA’s website.
Consumers can contact Inmar at 1-888-686-5002 for assistance with a recalled sample or any questions they may have about the recall. Product complaints and adverse events can be reported to Novo Nordisk’s Customer Care Center at 1-800-727-6500. Adverse events can also be reported to the U.S. FDA’s MedWatch program.
There is no member impact through Benecard Central Fill.