HYDERABAD, May 7: 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. (PTI)
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