Vivimed recalls hypertensive drug from US market due to impurities

 HYDERABAD, May 7: Vivimed Life Sciences Pvt Ltd, acity-based pharma company has started recalling 19 lots ofLosartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg toconsumer level in US, as the product was found to haveimpurities that may cause cancer, a US Food and DrugAdministration said.The product is made by Vivimed at its Plant in Alathur,Chennai and distributed by Heritage Pharmaceuticals Inc, EastBrunswick NJ in the US.To date, neither Vivimed nor Heritage has received anyreports of adverse events related to this recall, it said."Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100mg to consumer level due to detection of an impurityN-Nitroso-N-methyl-4-aminobutyric acid (NMBA) that is abovethe US Food and Drug Administration's interim acceptableexposure limit of 9.82 ppm.Based on the available information, the risk ofdeveloping cancer in a few patients following long-term use ofthe product containing high levels of the impurity NMBA cannotbe ruled out," the FDA said.Losartan Potassium is indicated for the treatment ofhypertension, hypertensive patients with left ventricularhypertrophy, nephropathy in Type 2 diabetic patients and ispackaged in 90-count and 1000-count bottles.Torrent Pharmaceuticals Ltd also started recallingcertain batches of Losartan Potassium Tablets USP and LosartanPotassium/hydrochlorothiazide tablets, USP, to the consumerlevel due to the detection of trace amounts of an unexpectedimpurity found in an active pharmaceutical ingredient (API)manufactured by Hyderabad-based Hetero Labs Ltd. (PTI)