Torrent Pharma which is based at Ahmedabad has been recalling 20,952 cartons of Telmisartan tablets that are used in the treatment of hypertension in US manufactured at its Indrad facility on account of presence of ‘foreign substance’ in them.
According to the latest US Food and Drug Administration (USFDA) enforcement report, the tablets in the strength of 80 mg are made by Torrent for its US arm Torrent Pharma Inc.
USFDA has said that Torrent is recalling the tablets in a firm initiated ongoing nationwide Class III recall because of “presence of foreign substance: product complaint for the presence of foreign matter identified as silicon within the tablet.”
According to the USFDA, a Class III recall has been initiated in a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences.