Novo Nordisk Recalls Samples of Levemir, Tresiba, Fiasp, Novolog, and Xultophy Due to Improper Storage Temperature Conditions
Washington, D.C. – According to a U.S. Food and Drug Administration recall announcement published on May 10, 2021, Novo Nordisk has initiated a nationwide recall of 1,468 product samples of Levemir®, Tresiba®, Fiasp®, Novolog,® and Xultophy®, distributed at the consumer level. Novo Nordisk recalled the affected product samples (please refer to the table below) due to “improper storage temperature conditions.” According to the recall announcement, diabetes patients taking any of the recalled product samples could suffer life-threatening hyperglycemia or hypoglycemia.
According to Novo Nordisk, the company hasn’t received any severe medical adverse events, injuries, or deaths connected to this nationwide recall. The medication samples affected by this recall were damaged after they were stored in temperatures below the storage requirements. In the event these medications are exposed to sub-freezing temperatures, the medications lose efficacy. The recall announcement also reported that if the medications were not properly stored, the patient might not receive the full amount of the medication because the pen injectors and cartridges can also become damaged if exposed to sub-freezing temperatures.
The recall only affects the company’s product samples and not the medications distributed to pharmacies or through mail order services.
The recalled medications are used to reduce blood glucose levels in individuals with Type I diabetes. The products were packaged in cartons with either a FlexPen,® FlexTouch® pen injector or a PenFill® cartridge.
Novo Nordisk is recalling approximately 1,468 product samples that are listed in the table below.
The affected medications can be identified by simply checking the lot number or the batch number that is found on the product’s packaging and comparing it to the list above. Novo Nordisk states that they have contacted all physician offices that have the recalled samples, and the company has also requested that the samples be returned. Any customer who received one of the recalled samples from their physician’s office should’ve received a warning letter from their physician.
The lot numbers and batch numbers of the recalled product samples of Levemir,® Tresiba,® Fiasp,® Novolog,® and Xultophy®.
|Product Name||NDC #||Batch #||# of Affected Expiration||Expiration Date|
|Fiasp® FlexTouch®||0169-3204-90 (Pen)||KP51207||24||6/30/22|
|Levemir® FlexTouch®||0169-6438-98 (Kit)||KP51933||7/31/22|
|NovoLog® FlexPen®||0169-5339-98 (Kit)||KS6BS11||11/30/21|
|Tresiba® U100||0169-2660-90 (Pen)||KP52035||12||4/30/22|
|Tresiba® U200||0169-2550-90 (Pen)||KP51059||8||11/30/21|
|Xultophy® Pen||0169-2911-97 (Kit)||JP54291||3||6/20/21|
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