FDA MedWatch - Levemir, Tresiba, Fiasp, Novolog and Xultophy Product Samples by Novo Nordisk:

Recall - Due to Improper Storage Temperature Conditions

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Levemir, Tresiba, Fiasp, Novolog and Xultophy Product Samples by Novo Nordisk: Recall - Due to Improper Storage Temperature Conditions AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: Novo Nordisk is recalling 1,468 product samples of Levemir, Tresiba, Fiasp, Novolog and Xultophy because they were stored at temperatures below storage requirements. This recall only impacts product samples and does not impact product that has been broadly distributed to pharmacies or mail-order services. 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. Novo Nordisk has not received any reports of serious adverse events or injuries related to this recall. For more information about this recall and the list of affected lots, click on the red button "Read Recall" below. BACKGROUND: Levemir, Tresiba, Fiasp, Novolog and Xultophy 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).  RECOMMENDATIONS: 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.  Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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