Novo Nordisk Issues Voluntary Recall of Insulin Samples

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Novo Nordisk Issues Voluntary Recall of Insulin Samples

Insulin manufacturer Novo Nordisk issued a voluntary recall of 1,468 insulin product samples due to improper storage conditions, as announced in a news release from the company.

The recall affects only product samples, not insulin distributed by pharmacies or mail order. Affected products include Levemir, Tresiba, Fiasp, Novolog, and Xultophy. According to the company, the affected batches of these products were “stored at temperatures below storage requirements.” Storage at a lower-than-recommended temperature is not likely to affect the potency of the insulin formulation, but may result in problems with how the insulin is delivered, according to the release.

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The company explained: “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.”

So far, though, Novo Nordisk has not received any reports of serious adverse events related to the affected batches of insulin. If you do experience an adverse event from one of these product samples, the company notes, you can contact Novo Nordisk’s Customer Care Center at 1-800-727-6500, Monday through Friday, 8:30 AM to 6:00 PM EDT. You can also report an adverse event to the US Food and Drug Administration (FDA)’s MedWatch Adverse Event Reporting program.

Batch numbers of all Novo Nordisk insulin products are printed on the product packaging, as well as on the product itself (for example, on an insulin pen). The batch number is printed under the product’s expiration date. The affected batch numbers can be found in the company’s press release on the recall. Anyone who received an affected product sample from their doctor’s office should also have received a letter about the recall from their doctor, according to the company.

If you have a product sample that is affected by the recall, you should contact the Novo Nordisk recall processor Inmar at 1-888-686-5002, Monday through Friday, 9:00 AM to 5:00 PM EDT. Following this procedure may allow you to obtain a replacement for the affected product.

Guidelines for storing insulin don’t end at your doctor’s office or pharmacy — it’s important to follow your product label’s instructions for storing insulin. While most insulin products will remain potent at room temperature for a long period of time, it’s still advised to store unopened insulin in your refrigerator according to product guidelines, and to avoid exposure to high temperatures even when a product isn’t supposed to be stored in a refrigerator.

Want to learn more about insulin? Read “What Does Insulin Do?” “Insulin: What You Need to Know” and “Insulin Basics.”

Quinn Phillips

Quinn Phillips

Quinn Phillips on social media

A freelance health writer and editor based in Wisconsin, Phillips has a degree from Harvard University. He is a former Editorial Assistant for Diabetes Self-Management and has years of experience covering diabetes and related health conditions. Phillips writes on a variety of topics, but is especially interested in the intersection of health and public policy.

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