Teva Pharmaceuticals USA, a subsidiary of Teva Pharmaceutical Industries, has started a voluntary recall of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25mg strength and 29 lots of 100mg strength) in the United States, it was reported on Friday.
The company is recalling the product because of the detection of an impurity, N-Nitroso-N-methyl-4-aminobutyric acid, found in six lots of active pharmaceutical ingredient produced by Hetero Labs Limited that is above the US Food & Drug Administration's (FDAs) interim acceptable exposure limit of 9.82 ppm.
The product is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. The lots were sold exclusively to Golden State Medical Supply of Camarillo, California. Golden State Medical Supply packages this bulk product under its own label and distributes in retail bottles of 30, 90, and 1000 tablets.
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