If Your Doctor Gave You a Sample of This Medication, Don't Use It, FDA Warns
Taking this medication can lead to adverse health consequences.
If your prescription hasn't been working for you or your doctor plans to put you on a new medication, they'll often times give you a free sample of a medication to try it out without having to commit to ordering a full amount. But now, one type of a medication sample could be putting you at risk, according to a new announcement from the Food and Drug Administration. Global healthcare company Novo Nordisk is recalling a number of samples of its insulin medication taken for diabetes, a condition that affects 34.2 million people across the U.S., according to the Centers for Disease Control and Prevention (CDC). Keep reading to learn what medicine samples you should not be using.
Novo Nordisk has recalled 1,468 samples of its insulin products.
On May 7, Novo Nordisk announced it has voluntarily recalled 1,468 product samples of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy®, all insulin products used to lower blood glucose levels in people with diabetes. In its announcement of the insulin sample recall, Novo Nordisk says the products in question "are packaged in cartons with either a vial, pen-injector (FlexPen® or FlexTouch®) or a cartridge (PenFill®)."
The recall, which was posted by the FDA on May 10, doesn't affect prescribed doses of the insulin—none of the insulin that was distributed to pharmacies or sent via mail-order services have been impacted. You can check the full list of affected insulin samples on the company's official notice.
And for more news delivered right to your inbox, sign up for our daily newsletter.
The issue with these product samples is that they were not stored within the correct temperature requirements.
As we now know in regards to the COVID vaccine, medication being stored at the correct temperature is key to its effectiveness, and that's exactly where things went wrong with these insulin samples.
"These products are being recalled because they were stored at temperatures below storage requirements," the recall notice explains. The products' cartridge and pen-injectors could be damaged if they are exposed to conditions below 32 degrees Fahrenheit, the company says. Incorrect temperatures could also cause diminished product efficacy.
Fierce Pharma reports the storage issue was the result of power outages from storms in Texas earlier this year, while others were due to human error at doctors' offices. The website says "Novo has about 1.5 million samples in-market at a time," meaning the recall affects .1 percent of its samples.
The products in question can be identified by checking the batch number or lot number on the packaging, and matching those numbers to the list of affected insulin samples on Novo Nordisk's website.
Using improperly stored products could be "life-threatening."
In the recall notice, Novo Nordisk says: "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."
Thankfully, as of May 7, no reports of serious adverse events or injuries had been reported to Novo Nordisk due to the insulin samples in question. All doctors' offices that obtained the now-recalled samples have been contacted and urged to return the products. Customers who acquired the insulin through their doctors should have received a letter about the recall from their physician.
Novo Nordisk is urging anyone who has experienced an adverse event, or who simply has a complaint, to contact their customer care center at 800-727-6500 on weekdays between 8:30 a.m. and 6 p.m. ET. Additionally, reports can be sent to the FDA's MedWatch Adverse Event Reporting Program online.
Novo Nordisk previously recalled other insulin products a few years ago.
In 2017, Novo Nordisk voluntarily recalled a batch of its NovoPen Echo® insulin cartridge holders "because they may crack or break if exposed to certain chemicals, like certain cleaning agents," the company said in its announcement at the time, which was also posted on the FDA website. They issued the recall after having "received numerous complaints of damaged cartridge holders," adding they had "received some reports of adverse events to date."
"Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar," the company said. They issued replacement cartridge holders for six batches of the NovoPen Echo®.