Indian pharmaceutical company Torrent Pharmaceuticals Limited has announced a voluntary recall of an additional 36 batches of Losartan potassium Tablets USP and 68 batches of Losartan Potassium / Hydrochlorothiazide Tablets USP, in which were found traces of dangerous substances — N-nitroso-N-methyl-4-aminobutyric acid (NMBA), which is classified as a “potential human carcinogen“.
Management on sanitary inspection behind quality of foodstuff and medicines USA (Food and Drug Administration — FDA) has published the corresponding statement on Thursday, April 18.
Indian pharmaceutical company says it is Recalling lots that were discovered NMBA in amounts “in excess of the allowable daily intake levels recommended by the FDA”. To date, the pharmaceutical company has not received any reports about any side effects provoked by taking losartan.
The FDA recommends that patients taking drugs from the recalled batches, continue to take them until their doctor/pharmacist will not provide a replacement or other treatment option. All patients should immediately consult their doctors.
This is the latest opinion in a series of reviews, followed each other since the summer of 2018. Then the regulator has become aware that some generic drugs used for the treatment of hypertension, contain impurities of nitrosamines including N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which are probable carcinogens for humans. This was the reason for the global recall USA of drugs, such as valsartan, irbesartan, losartan, etc., and a large-scale investigation.
According to the preliminary assessment of the FDA, the cause of hazardous substances in these drugs, presumably, was the repeated use in the production of certain reagents, solvents and other materials.
Torrent Pharmaceuticals Ltd has recalled more than 100 batches of blood-pressure medication in the United States updated: APR 21, 2019 author: Natalia Osmolovskaya