According to a report from USA Today, the Food and Drug Administration recalled more than 7,000 bottles of an antidepressant because of a chemical. The recall was initiated earlier this month on October 10. The antidepressant, duloxetine, reportedly known under brands such as Cymbalta, is used to treat mental health conditions such as anxiety and depression.

The product was distributed throughout the country and was manufactured by Towa Pharmaceutical Europe, the report said. The FDA says the drug contained the “presence” of a nitrosamine drug substance impurity, N-nitroso-duloxetine.

According to the FDA, nitrosamine impurities “may increase the risk of cancer if people are exposed to them at levels above acceptable levels and for long periods of time.” However, it adds, “The risk of cancer is not expected to be increased in a person taking a medicine containing nitrosamines below the acceptable daily intake limit every day for up to 70 years.”

The FDA says #220128 was the recalled lot with an expiration date of December 2024.

Nitrosamines are chemical compounds, some of which are carcinogenic. They are formed by the reaction between nitrite and secondary amines. They may be in many products such as processed meat, cosmetics, rubber and pharmaceuticals.

Nitrosamines may be a cause for concern because they can form during food processing or preservation, especially when nitrites are used to inhibit bacterial growth. High cooking temperatures, such as frying or grilling, can also help with their formation.

In the human body, nitrosamines are associated with an increased risk of cancer, especially stomach, esophagus, and liver cancer because they can damage DNA.

Regulatory agencies have established limits on nitrosamine levels in pharmaceuticals and foods to reduce these risks. To reduce the risk, it is important to limit consumption of processed meat, use less nitrate-preserved foods, and choose fresh and minimally processed ingredients.

There have been several cases where nitrosamines have been discovered in medicines in recent years. This has led to recalls and increased scrutiny of manufacturing processes. More than 12 million bottles of blood pressure-lowering drugs such as valsartan and losartan have been removed from the market since 2018 because they contained nitrosamines.

The same family of polluters recalled heartburn drug Zantac, diabetes drug metformin and smoking cessation drug Chantix.

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