PLAINSBORO, N.J., May 7, 2021 /PRNewswire/ -- 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
|
24
|
06/30/2022
|
KP52618
|
153
|
10/31/2022
|
Fiasp®
PenFill®
|
0169-3205-91
|
KS6BF84
|
7
|
06/30/2022
|
Fiasp®
Vial
|
0169-3201-90
|
KS6BX63
|
90
|
10/31/2022
|
KS6AK76
|
10
|
05/31/2022
|
KS6BR92
|
20
|
09/30/2022
|
Levemir®
FlexTouch®
|
0169-6438-90
(Pen)
0169-6438-98 (Kit)
|
KP51933
|
24
|
07/31/2022
|
NovoLog®
FlexPen®
|
0169-6339-90
(Pen)
0169-5339-98 (Kit)
|
KS6BS11
|
44
|
11/30/2021
|
NovoLog® Vial
|
0169-7501-90
|
JZFC826
|
17
|
06/30/2021
|
KZFM305
|
26
|
08/31/2022
|
Tresiba® U100
FlexTouch®
|
0169-2660-90
(Pen)
0169-2660-97 (Kit)
|
JP52771
|
13
|
09/30/2021
|
JP53136
|
4
|
06/30/2021
|
KP50575
|
30
|
01/31/2021
|
KP50976
|
27
|
01/31/2022
|
KP51813
|
99
|
04/30/2022
|
KP52035
|
12
|
04/30/2022
|
KP52117
|
36
|
04/30/2022
|
KP52440
|
207
|
06/30/2022
|
KP52461
|
60
|
04/30/2022
|
KP52616
|
81
|
06/30/2022
|
JP52361
|
7
|
08/1/2021
|
Tresiba® U200
FlexTouch®
|
0169-2550-90
(Pen)
0169-2550-97 (Kit)
|
KP52829
|
170
|
07/31/2022
|
JP54181
|
12
|
09/30/2021
|
KP51059
|
8
|
11/30/2021
|
KP51865
|
182
|
11/30/2021
|
KP54179
|
68
|
11/30/2022
|
JP52179
|
20
|
08/16/2021
|
Tresiba® Vial
|
0169-2662-90
|
JZFE233
|
14
|
11/30/2021
|
Xultophy® Pen
|
0169-2911-90
(Pen)
0169-2911-97 (Kit)
|
JP54291
|
3
|
06/20/2021
|
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:
www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form
www.fda.gov/MedWatch/getforms.htm 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.
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SOURCE Novo Nordisk