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More than 7,000 bottles of the antidepressant duloxetine have been recalled across the United States after they were found to contain levels of a potentially cancer-causing chemical above the limit set by the U.S. Food and Drug Administration (FDA).
The notice points to the presence of a chemical called N-nitroso-duloxetine that is above the agency’s “proposed interim limit.”
Approximately 7,100 bottles of Duloxetine have been recalled nationwide, including 500 delayed-release 20-milligram capsules, the FDA’s notice states.
The recalled bottles have a lot number of 220128 and an expiration date of 12/2024, according to the notice, which classifies the recall as a Class II.
According to the FDA’s notice, the recalled bottles of duloxetine were distributed across the United States.
One potential source includes the drug’s manufacturing process. Chemical structure and the conditions in which the drugs are stored or packaged may also contribute to the presence of nitrosamine impurities, the FDA states.
As foods and drugs are processed in the body, nitrosamines can also be formed.
The FDA notes that nitrosamines are commonly found in water and foods, including cured and grilled meats, dairy products, and vegetables, and that everyone is exposed to some level of nitrosamines.
However, long-term exposure can lead to an increased risk of cancer.
“Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but 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,” the FDA states.
“FDA continues to test and research possible sources for drugs found to contain nitrosamines.”