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The U.S. Food and Drug Administration (FDA) has recently announced a Class 2 recall involving 700 bottles of Duloxetine, a commonly prescribed medication used to treat conditions such as depression, anxiety, and nerve pain. This FDA recalls Duloxetine because immense concerns were raised about potential safety issues with specific batches. In this blog, we’ll discuss the details of the recall, what a Class 2 recall means, and the steps affected patients and healthcare providers should take.

Why Has the FDA Announced A Class II Recall of 700 Bottles of Duloxetine?

On October 10th, the Food and Drug Administration announced a Class II recall of 700 bottles carrying Duloxetine due to the excessive amounts of impurities of N-nitroso- duloxetine drug that is considered to be a cancer-causing chemical. The FDA and other food and drug regulatory bodies around the world have set international standards regarding the usage of this drug, stating that it should not be over 600 ng/day. 

Over here, the manufacturers and distributors, who were none other than Towa Pharmaceutical Company Europe, heavily violated the rules by adding 20 Mg. Therefore, the FDA took this action, offering them another opportunity to improve the medicine so that it becomes safe for consumption. On the other hand, the pharmaceutical company discussed the recall with Health and said that they are collaborating and working with the FDA and other related authorities to implement the decision. Their team is working on those anti-depressants as they are not in favor of compromising patient safety. Hence, people need to give them some time before Duloxetine shows up again in the market. 

What Is Class II Recall? 

Since it is a Class II recall, let us clarify your concept related to this classification. It is defined as a situation where if an individual tends to use medicine more than the prescribed limit, then that can lead to temporary negative health conditions, and they have narrow chances of recovery.

Duloxetine and Its Purpose 

We are sure you must be wondering what Duloxetine is. It is an antidepressant whose brand name is Cymbalta, which individuals suffering from depression consume to cure their anxiety and depression. However, the Mayo Clinic shares that the same medicine can also be taken to reduce pain caused by the damage of nerves linked with diabetes. 

FDA recalls Duloxetine: Why?

The primary reason why FDA recalls Duloxetine is that the medication which is supposed to treat patients suffering from depression or anxiety, have been found with extra amounts of Nitrosamine.

What Is Nitrosamine? 

For individuals who are hearing about nitrosamine for the first time, let us inform you that these are chemical compounds, and some of them are carcinogenic, too. When nitrites and secondary amines react together, you get Nitrosamine. They are present in many products, such as cosmetics, rubber, processed meats, and pharmaceuticals as well. A toxicologist at MedStar Health, Kelly Johnson Arbor, MD, shared with Health that Nitrosamines are chemicals found in a variety of foods, the water you drink, cosmetics individuals use, and tobacco products.