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Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg after NDEA is found in finished product manufactured with API made by Hetero Labs Limited.
FDA announced on Feb. 22, 2019 that Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg because of trace amounts of N-nitrosodiethylamine (NDEA) detected in finished product manufactured with API made by Hetero Labs Limited. The company is recalling the product because the level of NDEA, which is classified as a probable human carcinogen, is above acceptable daily intake levels.
Losartan Potassium/Hydrochlorothiazide combination tablets are used to treat hypertension and hypertensive patients with left ventricular hypertrophy. The company has not received any reports of adverse events and recommends patients keep taking their medication, “as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.”
Several products from different manufacturers were also recalled in 2018 and early 2019 due to the presence of NDEA. FDA and the European Medicines Agency (EMA) have been conducting investigations into the situation, and EMA has required manufacturers to review their processes.