Ahemdabad based Torrent Pharma is recalling 20,952 cartons of Telmisartan tablets used for treatment of hypertension in US manufactured at its Indrad facility due to presence of 'foreign substance' in them.
The tablets in the strength of 80 mg are made by Torrent for its US arm Torrent Pharma Inc, the latest US Food and Drug Administration (USFDA) enforcement report said.
Torrent is recalling the tablets in a firm initiated ongoing nationwide Class III recall on account of "presence of foreign substance: product complaint for the presence of foreign matter identified as silicone within the tablet", US health regulator said.
As per USFDA, a Class III recall is initiated in a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
