Drug firm Torrent Pharma Inc is recalling over 8.82 lakh bottles of Losartan Potassium tablets, used for treatment of hypertension, from the US and Puerto Rico markets on account of deviations from the current good manufacturing norms, according to a report of the US health regulator.
The US-based arm of Torrent Pharmaceuticals is recalling 28,464 bottles of Losartan Potassium tablets USP in the strength of 25 mg manufactured by the parent company at its Indrad facility in Mehsana district, the latest Enforcement Report of the the United States Food and Drug Administration (USFDA) said.
The company is also recalling 164,424 bottles of Losartan Potassium tablets, USP, 50 mg from the US and Puerto Rico, the regulator said.
The company is recalling 3,31,764 bottles of Losartan Potassium and Hydrochlorothiazide tablets, USP, 50mg/12.5mg from US and Puerto Rico, the report said.
As many as 54,084 bottles of Losartan Potassium and Hydrochlorothiazide tablets, USP, 100mg/12.5mg, are also being recalled from these markets, it added.
All the ongoing voluntary recalls of the hypertension treatment drug are class II recalls, it added.
The reason for the recalls is "CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million", the report said.
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the USFDA.
As per the USFDA, a class II recall is initiated in a situation "in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".
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