Torrent Pharmaceuticals Limited Expands Recall of Losartan Potassium Tablets
January 08, 2019 at 11:21 am
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Torrent Pharmaceuticals Limited announced that it is expanding its recall of Losartan potassium tablets because of the detection of trace amounts of N-nitrosodiethylamine, or NDEA, above the acceptable daily intake levels released recommended by the U.S. Food and Drug Administration. Torrent Pharmaceuticals recalled two lots of the tablets in December, but the recall has now widened to 10 lots. An unexpected impurity was found in an active pharmaceutical ingredient manufactured by Hetero Labs Limited. The Medication is used by patients to treat high blood pressure and diabetic kidney disease. Last week, 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP were recalled because of the presence of NDEA. Drugs involved in the recall are all part of a large class of drugs called angiotensin II receptor blockers, which work by blocking the effects of a hormone that narrows blood vessels.
Torrent Pharmaceuticals Limited is an India-based pharmaceutical company. The Company is focused on various therapeutic segments, such as cardiovascular (CV), central nervous system (CNS), gastrointestinal (GI), vitamins minerals nutrients (VMN), anti-diabetes (AD), pain, gynecology, and dermatology. The Company is engaged in research, development, manufacturing, marketing and distribution of branded and generic pharmaceutical formulations in India and internationally. Its pediatric product brands include Tedibar, Atogla, Spoo and B4 Nappi. Its acne/facecare products brands include Clinmiskin, ACNEMOIST, TRACNILO and fash. The Company's hair/scalp care products brands include Proanagen, Perlice, Permite and NOSKURF. Its manufacturing facilities are located in the states of Gujarat, Himachal Pradesh, Madhya Pradesh, Andhra Pradesh and Sikkim. The Company's primary channel of distribution is through the wholesale drug distributors, stockiest and retail pharmacies.