Recall of Product Samples from U.S. Market Due to Improper Storage Temperature Conditions

Recommendation

7 September 2022
Bern, Switzerland

GDP in Switzerland (GDP 3)
Specifics in the Distribution of Medicinal Products (Course in english language!)

Novo Nordisk, a global healthcare company, is voluntarily recalling 1,468 product samples of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® from the U.S. market. These products are used to lower blood glucose levels in people with diabetes. They are packaged in cartons with either a vial, pen-injector or a cartridge.

The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). It only impacts product samples and has no influence on product that has been broadly distributed to pharmacies or mail-order services. The company has already informed physician offices that received affected samples and requested all impacted samples to be returned.

The reason for the recall is that the products were stored at temperatures below storage requirements.

In a company announcement, the following is stated: "If product samples are exposed to temperatures below 32°F, it could cause a lack of efficacy and damage to the cartridge and pen-injectors. If product from an improperly stored vial, cartridge or pen-injector is used, there is a risk that you might not receive the right amount of medicine as intended which may lead to hyperglycemia or hypoglycemia resulting in adverse health consequences ranging from limited to life-threatening."

According to the information published, Novo Nordisk has not received any reports of serious adverse events or injuries related to this recall.

The products can be identified by looking for the batch number or lot number located on the product or carton. A list of the lots affected and further information on how to proceed if product samples match a batch number can be found in the company announcement published on the FDA website.