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Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to Improper Storage Temperature Conditions

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs

Reason for Announcement:

Recall Reason Description

Due to improper storage temperature conditions

Company Name:
Novo Nordisk
Brand Name:

Brand Name(s)

Levemir, Tresiba, Fiasp, Novolog and Xultophy

Product Description:

Product Description

Product Samples


Company Announcement

Novo Nordisk is voluntarily recalling 1,468 product samples listed in the table below of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy®, to the consumer level. These products are being recalled 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.

These 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®). A list of the affected lots can be found in the chart below:

Product NameNDC #Batch ## of Affected
Samples
Expiration
Date
Fiasp® FlexTouch®0169-3204-90 (Pen)KP512072406/30/2022
 0169-3204-97 (Kit)KP5261815310/31/2022
Fiasp® PenFill®0169-3205-91KS6BF84706/30/2022
  KS6BX639010/31/2022
Fiasp® Vial0169-3201-90KS6AK761005/31/2022
  KS6BR922009/30/2022
 0169-6438-90 (Pen) 24 
Levemir® FlexTouch®0169-6438-98 (Kit)KP51933 07/31/2022
 0169-6339-90 (Pen) 44 
NovoLog® FlexPen®0169-5339-98 (Kit)KS6BS11 11/30/2021
NovoLog® Vial0169-7501-90JZFC8261706/30/2021
  KZFM3052608/31/2022
  JP527711309/30/2021
  JP53136406/30/2021
  KP505753001/31/2021
  KP509762701/31/2022
  KP518139904/30/2022
Tresiba® U1000169-2660-90 (Pen)KP520351204/30/2022
FlexTouch®0169-2660-97 (Kit)KP521173604/30/2022
  KP5244020706/30/2022
  KP524616004/30/2022
  KP526168106/30/2022
  JP52361708/1/2021
  KP5282917007/31/2022
  JP541811209/30/2021
Tresiba® U2000169-2550-90 (Pen)KP51059811/30/2021
FlexTouch®0169-2550-97 (Kit)KP5186518211/30/2021
  KP541796811/30/2022
  JP521792008/16/2021
Tresiba® Vial0169-2662-90JZFE2331411/30/2021
 0169-2911-90 (Pen)   
Xultophy® Pen0169-2911-97 (Kit)JP54291306/20/2021

The product can be identified by looking for the batch number or lot number located on the product or carton and matching it to the list above. 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. If product samples match a batch number above or there are any questions about the recall, please contact the Novo Nordisk recall processor Inmar at 1-888-686-5002, Monday through Friday, 9:00 AM to 5:00 PM EDT.

Please report any complaints and adverse events to Novo Nordisk’s Customer Care Center which can be reached at 1-800-727-6500, Monday through Friday, 8:30 AM to 6:00 PM EDT.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Novo Nordisk
Novo Nordisk is a global healthcare company that’s been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in six states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk.us, Facebook, Instagram and Twitter.

Further information
Media:
Michael Bachner     609-664-7308     [email protected]

Investors:
Mark Joseph Root     +45 3079 4211     [email protected]


Company Contact Information

Consumers:
Novo Nordisk recall processor Inmar


Product Photos

Go to Source
Author: FDA

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