Recall of drugs containing nitrosamine impurities has led to a sanction of drugs made up of fluoxetine.
The Food and Drug Safety Administration issued an order to recall International Fluoxetine Capsules on May 10th as a precautionary measure due to the detection of excess impurities (N-Nitroso-Fluoxetine), and a recall of products on the market is underway. N-Nitroso-Fluoxetine is a nitrosamine contaminant originated from the fluoxetine ingredient.
The recall applies to 7 manufacturing numbers: CFT12102D, CFT12201B, CFT12201D, CFT12202B, CFT12202D, CFT12301D, and CFT12303D. The products have a shelf life of 36 months from the manufacturing date.
Fluoxetine is used for depression, nervous anorexia, obsessive-compulsive disorder, and premenstrual dysphoric disorder.
Concerns have been raised over the detection of impurities (NTTP) in diabetes combination drugs containing the ingredients sitagliptin and dapagliflozin this year. This is the first time in Korea that a fluoxetine drug has been recalled due to the risk of impurities.
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