Tresiba FDA Alerts

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

May 10, 2021 -- 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:

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.

Source: FDA

Caution When Using Pen Needles to Inject Medicines: FDA Safety Communication

Audience:

• Patients and caregivers who use or are considering using pen injectors with pen needles to inject prescription medicines.
• Health care providers who treat patients, or who train users on pen needles and pen injectors

Specialties

Health care providers including Nurses, Nurse Practitioners, Physician Assistants, Health Educators, Pharmacists, and Physicians

Device

Pen needles are used to inject medicine with pen injectors. For example, when insulin is packaged in a multi-dose pen injector, a new pen needle is used each time to inject the insulin.

Common types of pen needles include standard pen needles and safety pen needles. Standard pen needles often have an outer cover and a removable inner needle cover, which are both removed before an injection. Safety pen needles are different. They have an outer cover that is removed, and a fixed inner needle shield that is not removed before an injection.

Standard pen needles often have an outer cover and a removable inner needle cover. Both the outer cover and the inner needle cover must be removed before an injection.

Safety pen needles have an outer cover and a fixed inner needle shield (sharps injury prevention feature). The outer cover is removed before an injection, but the fixed inner needle shield is NOT removed before an injection.

Purpose

The FDA is providing recommendations to patients, caregivers, and health care providers to promote the safe use of pen needles used to inject medicines from pen injectors.

Summary of Problem and Scope

Pen needles are used with pen injectors to inject different types of medicines. The same pen injector can be used with both standard and safety pen needles. It is possible that patients could be taught using one type of pen needle, then receive the other type later. This could cause confusion about how to use the pen needle correctly, and may prevent the patient from getting the medicine they need.

The FDA has received reports of patients using standard pen needles to inject insulin without removing the inner needle cover. In these cases, the inner cover stopped the needle from entering the skin and the patients did not get the insulin. Some patients developed high blood sugar (hyperglycemia) because the inner needle cover stopped them from getting insulin.  One patient was hospitalized and died because of having blood sugar that was too high for too long.   

To help people use pen needles safely, the FDA recommends these actions:

Recommendations for Patients and Caregivers

• Each time you get a new box of pen needles, check to see if they are the same type as the ones you were trained to use. If not, ask your health care provider to show you how to use this new type properly.
• If you use a standard pen needle with an outer cover and an inner needle cover, be sure to remove both covers before use.
• If you feel like your medicine from the pen injector is not working, talk to your health care provider.
  • For example, if you have diabetes and your blood sugar levels are high after insulin injections, contact your health care provider to talk about your injection technique, insulin dosage, and other things that can affect your blood sugar levels.
• If you have any questions about your pen needle, contact your health care provider.

Recommendations for Health Care Providers and Health Care Educators

• Train and educate patients and caregivers:
  • Show them how to use the pen needle for their medication.
  • Ensure they can demonstrate correct technique to verify proper use of their pen needles.
  • Be sure they are aware of the different types of pen needles, and they know which type they use.
  • Explain the signs and symptoms of under-dose (and over-dose) of their medication, how to monitor their medical condition (for example, blood glucose levels), and when to contact their health care provider.
• Prescribers: Consider whether there could be a problem with an injection or medication administration technique before changing a medication dose.
• Pharmacists: When dispensing a new box of pen needles, consider asking the patient if they know how to use the type of pen needles being dispensed.
  • For example, remind patients that:
    • For standard pen needles with an outer cover and an inner needle cover, remove both covers before use.
    • For the safety pen needle, remove only the outer cover, as the fixed inner needle shield remains in place.
  • Be available to answer questions from patients and caregivers or refer them to their applicable health care provider.

FDA Activities

The FDA asked pen needle manufacturers to review their most recent labeling (that is Instructions or Directions for Use) and training materials to assess the need for updates to clearly explain how to use the pen needle safely. In addition, the FDA requested that standard pen needle manufacturers consider adding a warning in the labeling regarding the need to remove both the outer cover and the inner needle cover before use.

Reporting Problems to the FDA

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect or experience a problem with a pen needle, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Be sure to include:

• Device manufacturer and model of the pen needle
• The name of the medication being delivered through the pen needle (for example, the name of the pen injector)
• A clear description of event or issue and any applicable patient outcomes

Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Other Resources

• Institute for Safe Medical Practices, Severe Hyperglycemia in Patients Incorrectly Using Insulin Pens at Home
• Truong, T. H., Nguyen, T. T., Armor, B. L., & Farley, J. R. (2017). Errors in the Administration Technique of Insulin Pen Devices: A Result of Insufficient Education. Diabetes Therapy, 8(2), 221–226. https://doi.org/10.1007/s13300-017-0242-y
• American Diabetes Association
• NIH - Diabetes

Contact Information

If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.