Duloxetine is a common antidepressant sold under the brand name Cymbalta.
What Are Nitrosamines?
Everyone is exposed to some level of nitrosamines, the agency said.
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However, prolonged exposure to higher levels may elevate cancer risk.
The specific nitrosamine detected in Towas duloxetine is called N-nitroso-duloxetine.
Nitrosamines can form during chemical reactions during the drug manufacturing process and when it is packaged and stored.
The recall covers lot #220128, which expires on 12/2024.
If you are concerned about your medication being tainted, call your pharmacy.
The pharmacists can tell you if your batch is part of the recalled lot and what your options are.
They may be able to dispense duloxetine that is not part of the recall.
The FDA said not to abruptly stop taking your medication without consulting your health provider first.
The risks of stopping the medication may outweigh the potential risk of exposure to nitrosamines.
Food and Drug Administration.Recalls background and definitions.
Food and Drug Administration.Information about nitrosamine impurities in medications.
Food and Drug Administration.What to know and do about possible nitrosamines in your medication.
