Novo Nordisk recalls insulin samples due to improper storage temperature conditions
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Novo Nordisk announced a voluntary recall of select insulin product samples that were stored at temperatures below storage requirements, according to a company press release.
The recall, which includes samples of insulin detemir (Levemir), insulin degludec (Tresiba), rapid-acting insulin injection (Fiasp), insulin aspart (Novolog), and a fixed combination of insulin degludec and liraglutide (Xultophy) and does not affect insulin products broadly distributed to pharmacies or mail order services.
If product samples are exposed to temperatures below 32 degrees Fahrenheit, it could cause a lack of efficacy and damage to the cartridge and pen-injectors, according to the company. If product from an improperly stored vial, cartridge or pen-injector is used, there is a risk that a person with diabetes might not receive the right amount of medicine as intended, leading to hyperglycemia or hypoglycemia resulting in adverse health consequences ranging from limited to life-threatening. Novo Nordisk has not received any reports of serious adverse events or injuries related to this recall.
The products are used to lower blood glucose levels in people with diabetes and are packaged in cartons with either a vial, pen-injector (FlexPen or FlexTouch) or a cartridge (PenFill).
Novo Nordisk has notified all physician offices that received affected samples and requested all impacted samples be returned. Customers who received an affected sample through the physician's office should have received a letter from their physician.
Adverse events can be reported to Novo Nordisk's customer care center at 800-727-6500, Monday through Friday, 8:30 a.m. to 6 p.m. Eastern.
Adverse reactions or quality problems experienced may be reported to the FDA's MedWatch Adverse Event Reporting program at www.fda/medwatch/report.htm.
This recall is being conducted with the knowledge of the FDA.
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