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The company is voluntarily recalling six lots of Losartan potassium and hydrochlorothiazide tablets, USP because of the impurity, NDEA.
Torrent Pharmaceuticals Limited announced on Jan. 22, 2019 that it was expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include six lots of Losartan potassium and hydrochlorothiazide tablets, USP. The recall comes after trace amounts of N-nitrosodiethylamine (NDEA) were detected in API manufactured by Hetero Labs Limited.
According to the company, patients should continue to take their losartan, which is used to treat hypertension, because the risk to the patient’s health may be higher if they stop taking the medication without first discussing options with their physician. As of January 22, 2019, no adverse events had been reported in relation to the recalled products.
This recall joins a list of other products pulled off the market because of APIs containing NDEA. Both FDA and the European Medicines Agency have undergone investigations into the matter.