If your doctor gave you a sample of this medicine, do not use it, FDA warns
Taking this medicine can lead to harmful consequences for health.
If your order has not worked for you or your doctor plans to put you on a new drug, they will often give you a free medicine sample to try it without having to commit to order a total amount. But now, a type of drug sample could endanger you, according to a new announcement of the Food and Drug Administration. Global Healthcare Company Novo Nordisk isRecalling a number of samples of his medication of insulincaught for diabetes, a condition that affects 34.2 million people across the United States, according to disease control and prevention centers (CDC). Continue reading to learn the drug samples that you should not use.
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Novo Nordisk recalled 1,468 samples of insulin products.
On May 7, Novo Nordisk announced that it voluntarily recalled1,468 product samples Levemir®, Treesiba®, FiaSP®, Novolo® and Xultophy®, all insulin products used to reduce blood glucose levels in people with diabetes. In its announcement of the insulin reminder sample, Novo Nordisk states that the products in question "are packaged in cartons with a bottle, a pen-injector (Flexpen® or FLEXTOUCH®) or a cartridge (penfill)®) "
The reminder, which was published by the FDA on May 10, does not affect the prescribed doses of insulin - none of the insulin which was distributed to pharmacies or sent by email of the order services were affected. You can check theComplete list of insulin samples affected on the official opinion of the company.
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The problem with these product samples is that they were not stored in the correct temperature requirements.
As we now know with the Covid vaccine,medicine being stored at the correct temperature is the key to its effectiveness, and that's exactly where things have turned wrong with these insulin samples.
"These products are recalled because they have been stored at temperatures below storage requirements," says the recall advice. The product cartridge and pens injectors could be damaged if they are exposed to conditions below 32 degrees Fahrenheit, said the company. Incorrect temperatures could also result in a decrease in the efficiency of the product.
Fierce pharma reports that the storage question was the result ofPowers of storms in Texas Earlier this year, while others were due to a human error in the doctors' offices. The website indicates that "Novo has about 1.5 million market samples at a time, which means that the reminder affects .1% of its samples.
The products in question can be identified by checking the batch number or batch number on the package and corresponding to these numbers to theList of affected insulin samples on the Novo Nordisk website.
The use of poorly stored products could be "threatening life".
In the recall notice, Novo Nordisk says: "If the product of a bottle, a cartridge or a storage injector-injector is used, you may not receive the right amount of medicine as expected, which can Train hyperglycemia or hypoglycemia resulting in harmful consequences for health ranging from death to life life. "
Fortunately, as of May 7, no report of serious adverse events or injuries has been reported to Novo Nordisk because of insulin samples in question. All doctors offices that have obtained the samples now recalled have been contacted and invited to return the products. Customers who have acquired insulin through their doctors should have received a letter on the reminder of their doctor.
Novo Nordisk exhorts anyone who has experienced an adverse event or simply a complaint, contact their Customer Service Center at 800-727-6500 weekdays between 8:30 and 6 hours. AND. In addition, reports can be sent to theFDA MedWatch Adverse Event Reports Program in line.
Novo Nordisk previously recalled other insulin products a few years ago.
In 2017,Novo Nordisk voluntarily recalled A batch of his Novopen Echo® insulin cartridge holders "because they can crack or break if exposed to certain chemicals, like some cleaning agents," said the company in his ad at the time, who was also posted on the FDA website. They issued the reminder after "received numerous complaints from damaged cartridges", adding that they had "received adverse events reports to date".
"The use of a device with a cracked / broken cartridge holder can cause a reduced dose of insulin that can potentially lead to high blood glucose", said the company. They have issued replacement cartridges for six Novope Echo® lots.
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