COMPANY ANNOUNCEMENT
Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to Improper Storage Temperature Conditions
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason DescriptionDue to improper storage temperature conditions
- Company Name:
- Novo Nordisk
- Brand Name:
-
Brand Name(s)Levemir, Tresiba, Fiasp, Novolog and Xultophy
- Product Description:
-
Product DescriptionProduct 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 Name | NDC # | Batch # | # of Affected Samples |
Expiration Date |
---|---|---|---|---|
Fiasp® FlexTouch® | 0169-3204-90 (Pen) 0169-3204-97 (Kit) |
KP51207 --------------- KP52618 |
24 --------------- 153 |
6/30/2022 --------------- 10/31/2022 |
Fiasp® PenFill® | 0169-3205-91 | KS6BF84 | 7 | 6/30/2022 |
Fiasp® Vial | 0169-3201-90 | KS6BX63 --------------- KS6AK76 --------------- KS6BR92 |
90 --------------- 10 --------------- 20 |
10/31/2022 5/31/2022 9/30/2022 |
Levemir® FlexTouch® | 0169-6438-90 (Pen) 0169-6438-98 (Kit) |
KP51933 | 24 | 7/31/2022 |
NovoLog® FlexPen® | 0169-6339-90 (Pen) 0169-5339-98 (Kit) |
KS6BS11 | 44 | 11/30/2021 |
NovoLog® Vial | 0169-7501-90 | JZFC826 --------------- KZFM305 |
17 --------------- 26 |
6/30/2021 --------------- 8/31/2022 |
Tresiba® U100 FlexTouch® | 0169-2660-90 (Pen) 0169-2660-97 (Kit) |
JP52771 --------------- JP53136 --------------- KP50575 --------------- KP50976 --------------- KP51813 --------------- KP52035 --------------- KP52117 --------------- KP52440 --------------- KP52461 --------------- KP52616 --------------- JP52361 |
13 --------------- 4 --------------- 30 --------------- 27 --------------- 99 --------------- 12 --------------- 36 --------------- 207 --------------- 60 --------------- 81 --------------- 7 |
9/30/2021 --------------- 6/30/2021 --------------- 1/31/2021 --------------- 1/31/2022 --------------- 4/30/2022 --------------- 4/30/2022 --------------- 4/30/2022 --------------- 6/30/2022 --------------- 4/30/2022 --------------- 6/30/2022 --------------- 8/1/2021 |
Tresiba® U200 FlexTouch® | 0169-2550-90 (Pen) 0169-2550-97 (Kit) |
KP52829 --------------- JP54181 --------------- KP51059 --------------- KP51865 --------------- KP54179 --------------- JP52179 |
170 --------------- 12 --------------- 8 --------------- 182 --------------- 68 --------------- 20 |
7/31/2022 --------------- 9/30/2021 --------------- 11/30/2021 --------------- 11/30/2021 --------------- 11/30/2022 --------------- 8/16/2021 |
Tresiba® Vial | 0169-2662-90 | JZFE233 | 14 | 11/30/2021 |
Xultophy® Pen | 0169-2911-90 (Pen) 0169-2911-97 (Kit) |
JP54291 | 3 | 6/20/2021 |
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.
Company Contact Information
- Consumers:
- Novo Nordisk recall processor Inmar
- 1-888-686-5002