The Food and Drug Administration recalled more than 7,000 bottles of an antidepressant due to a chemical, according to a report in USA Today. The recall was initiated earlier this month on October 10. The antidepressant, Duloxetine, reportedly known under brands like Cymbalta is used to treat mental health conditions like anxiety and depression.
The report says that the product was distributed across the country and manufactured by Towa Pharmaceutical Europe. FDA says that the medication had the “presence” of nitrosamine drug substance impurity, N-nitroso-duloxetine. According to FDA, nitrosamine impurities “may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.
” However, it added, “a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.” FDA says that #220128 was the recalled lot which had an expiry date of December 2024. Nitrosamines are chemical compounds, some of which are carcinogenic.
They are formed by the reaction between nitrites and secondary amines. They can happen in several products such as processed meats, cosmetics, rubber and pharmaceuticals among others. Nitrosamines can be a cause of concern because they can form during food processing or preservation, especially when nitrites are used to prevent bacterial growth.
High cooking temperatures, such as frying or grilling can.