The U.S. Food and Drug Administration (FDA) has issued an immediate Class II recall for more than 7,000 bottles of an antidepressant due to the presence of a chemical impurity. According to the official report, the recall began on October 10.
Antidepressant Pulled from U.S. Market
Duloxetine, commonly known by brand names like Cymbalta, is used to treat mental health disorders such as anxiety and depression, among other conditions. The recalled product was distributed nationwide and manufactured by Towa Pharmaceutical Europe.
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In this case, the FDA confirmed that the medication contained an impurity known as N-nitroso-duloxetine, a nitrosamine compound. The agency stated that nitrosamine impurities “may increase the risk of cancer if people are exposed to them at levels above acceptable limits and for extended periods.”
However, the FDA also noted that “it is not expected that a person taking a medication with nitrosamines at or below acceptable daily intake limits for 70 years would have an increased risk of cancer.”
The FDA’s official statement reported that a total of 7,107 bottles were recalled. The recall operation was classified as a Class II event, meaning that exposure could cause “temporary or medically reversible adverse health consequences.”
The recalled batch, #220128, has an expiration date of December 2024. Authorities urged anyone in possession of medications with potential nitrosamine contamination to stop taking them immediately. “Patients should discuss their concerns and alternative treatment options with their healthcare providers,” the FDA advised.
What Are Nitrosamines?
Nitrosamines are chemical compounds that can form in certain foods, industrial products, or medications when amines (derived from proteins or chemicals) react with nitrites.
Some nitrosamines are considered cancer-causing, meaning they can increase the risk of cancer if exposure occurs over long periods at elevated levels.
Nitrosamines have been found in products like processed meats (especially those cured with nitrites), tobacco, some cosmetics, and recently, certain medications, such as this antidepressant.
Due to their potential health risks, authorities like the FDA regulate nitrosamine levels in consumer products to ensure they do not exceed acceptable limits.
This article was originally in Spanish by Miguel Fernández in CC News.
