Towa Pharmaceutical Recalls Duloxetine Over Nitrosamine Impurity; FDA Classifies as Class II Recall
核心洞察
Towa Pharmaceutical voluntarily recalled thousands of bottles of duloxetine 30 mg delayed-release capsules due to elevated levels of N-nitroso-duloxetine (搜索), a nitrosamine impurity.
The FDA has classified the recall as Class II, indicating the impurity may cause temporary or medically reversible adverse health consequences.
Nitrosamine impurities may increase cancer risk with long-term exposure above acceptable levels, though the FDA notes daily use at or below limits poses no elevated risk.
Towa Pharmaceutical has initiated a voluntary recall of thousands of bottles of the antidepressant duloxetine after testing revealed elevated levels of a nitrosamine impurity suspected of causing cancer. The recall, classified as Class II by the U.S. Food and Drug Administration, involves duloxetine delayed-release capsules at a dosage of 30 mg packaged in 1,000-capsule bottles.
The impurity identified is N-nitroso-duloxetine (搜索), a compound belonging to the nitrosamine class. Nitrosamines are commonly found in cured and grilled meats, dairy products, and vegetables, and may also appear as impurities in certain medications. According to the FDA, nitrosamine impurities "may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time."
Recall Classification and Risk Assessment
The FDA designated this recall as Class II, a classification applied when use of or exposure to a product may "cause temporary or medically reversible adverse health consequences." The agency has also stated that individuals who take medications containing nitrosamines, even daily for 70 years, are not expected to face an increased cancer risk provided the nitrosamine levels remain at or below the acceptable intake limits.
Affected Product Details
The recalled product is specifically identified by lot number 241180C, with an expiration date of April 2027. The duloxetine capsules are manufactured by Towa Pharmaceutical and distributed by Breckenridge Pharmaceutical Inc. (搜索) Duloxetine is a widely prescribed serotonin-norepinephrine reuptake inhibitor (SNRI) used in the treatment of major depressive disorder, generalized anxiety disorder, and certain chronic pain conditions.
Healthcare professionals and patients seeking additional information about the recall are encouraged to consult the FDA's recall notices and contact their healthcare provider with any concerns regarding continued use of the medication.