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Antidepressant Recalled Over Cancer Compound Fears
16 Jun
Summary
- Nearly 370,000 bottles of Duloxetine recalled for high impurity levels.
- Impurity, N-nitroso-duloxetine, is suspected of causing cancer.
- Recall is Class II, indicating temporary or reversible health consequences.
A significant voluntary recall has been issued for nearly 370,000 bottles of Duloxetine, a medication commonly prescribed for depression, anxiety, and nerve damage. The recall is due to the potential presence of N-nitroso-duloxetine impurity, which has been found above the Food and Drug Administration's recommended interim limit.
This impurity, N-nitroso-duloxetine, is identified as a substance suspected of causing cancer and is toxic if ingested. While exposure to nitrosamines, which are common in various foods and water, does not immediately cause cancer, prolonged exposure above acceptable levels may increase cancer risk. This recall has been classified as a Class II by the FDA.
Breckenridge Pharmaceutical, Inc., the distributor initiating the recall, has reported no known adverse events linked to this issue. This situation marks the second recall of Duloxetine for similar nitrosamine contamination, following a smaller recall of over 7,000 bottles in October 2024.
