Vivimed Life Sciences Pvt Ltd, a city-based pharma company has started recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level in US, as the product was found to have impurities that may cause cancer, a US Food and Drug Administration said.
The product is made by Vivimed at its Plant in Alathur, Chennai and distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ in the US.
To date, neither Vivimed nor Heritage has received any reports of adverse events related to this recall, it said.
"Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level due to detection of an impurity
N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) that is above the US Food and Drug Administration's interim acceptable exposure limit of 9.82 ppm.
Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out," the FDA said.
Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients and is packaged in 90-count and 1000-count bottles.
Torrent Pharmaceuticals Ltd also started recalling certain batches of Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hyderabad-based Hetero Labs Ltd.
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