Recall report: Novo Nordisk recalls samples of multiple insulin products after storage screw-up
Five different insulin drugs have been recalled by Novo Nordisk after the company says the samples were stored at the wrong temperature.
The recall affects 1,468 product samples of Levemir, Tresiba, Fiasp, Novolog and Xultophy. The recall only impacts samples, and not product that’s been distributed to pharmacies or mail-order services, the FDA said.
If samples are exposed to temperatures below 32 degrees Fahrenheit, it could damage the efficacy of the drug and the cartridge and pen-injectors. It that product is used, patients run the risk of not receiving the proper dosage, which could lead to hyperglycemia or hypoglycemia.
So far, Novo Nordisk hasn’t received any reports of serious side effects from the recall, the FDA said. The drugs are used to lower blood glucose levels in patients with diabetes, and the risk of potential side affects range from limited to life-threatening. The drug is packaged with either a vial, pen-injector or cartridge.
The batches affected are:
- 177 samples of Flasp FlexTouch
- 97 samples of Flasp PenFill
- 54 samples of Flasp Vial
- 44 samples of Levemir FlexTouch
- 216 samples of NovoLog Vial
- 12 samples of Tresiba U100
- 851 samples FlexTouch
- 8 samples of Tresiba U200
- 14 samples of Tresiba Vial
- 3 samples of Xultophy Pen.
Customers who receive an affected sample should also receive a letter from their doctor, as Novo Nordisk has reached out to the physicians’ offices that received the affected samples, the FDA said.