FDA Recall of Duloxetine Over 7,000 Bottles: Essential Information

(VOR News) – More than seven thousand bottles of the FDA antidepressant duloxetine, which is more commonly known by its brand name Cymbalta, have been recalled by the Food and Drug Administration (FDA) of the United States due to the presence of a chemical that has the potential to cause cancer due to its presence in the product.

The FDA says the chemical is in the product because it can cause cancer.

In light of the fact that the chemical was discovered in the product, the FDA came to this conclusion. Due to the fact that this recall was initiated on October 10th, individuals and professionals working in the healthcare business alike have expressed their worries in response to it.

The Food and Drug Administration (FDA) took this action as a result of the detection of N-nitroso-duloxetine, which is a nitrosamine impurity that was discovered in the drug that was being discussed.

The consumption of this pollutant in quantities that are greater than what is regarded as safe over a prolonged period of time has the potential to increase the risk of developing cancer.

This risk can be increased by consuming this contaminant. The Food and Drug Administration (FDA) has put tight restrictions on the amount of nitrosamines that can be found in medications.

This is in spite of the fact that nitrosamines are frequently seen in both food and water. To be more specific, the lot number that is being recalled is #220128, and the expiration date is not expected to take place until the month of December in the year 2024.

Number of Bottles Affected: There are a total of 7,107 bottles of Duloxetine that have been affected, including delayed-release capsules that contain 500 counts respectively. The affected bottles are all affected by the same issue.

The FDA has identified a single issue with all of the affected bottles.

This issue, which has been categorized as a Class II recall, has the potential to result in “temporary or medically reversible adverse health consequences,” as stated by the Food and Drug Administration (FDA).

This recall has been classified at the Class II level. Class II recall is the designation that has been given to this incident. The firm that is known as Towa Pharmaceutical Europe is the one that is responsible for the manufacturing of the product, which was then dispersed across the various areas that make up the nation.

The Food and Drug Administration (FDA) highly recommends that individuals who are in possession of these specific bottles of duloxetine immediately stop using the medication and discuss other treatment options with their healthcare practitioners.

This recommendation is to be taken seriously. Even though the Food and Drug Administration (FDA) stresses that patients should not suddenly stop taking any antidepressant prescription without the assistance of a specialist, individuals who have the medication that has been recalled should seek the opinion of a medical professional. This is because the FDA announced that the medication had been recalled.

It is possible for nitrosamines, which are also known as N-nitroso-duloxetine, to be produced either during the manufacturing process of a drug or even through the chemical structure of the drug itself.

Nitrosamines have the potential to be obtained in either of these two ways. There is an association between their presence and an increased risk of acquiring cancer when they are present in substantial numbers for an extended period of time.

This is evidenced by the fact that they are present. There are a few different kinds of food that contain them that can be found. A number of drugs have already been recalled by the Food and Drug Administration (FDA) due to the same concerns about nitrosamines.

The prescription medication Zantac, which is used to treat heartburn, and the medication metformin, which is prescribed for the treatment of diabetes, are both examples of medications that fall under this category.

SOURCE: SLN

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