Drug firm Torrent Pharmaceuticals Inc is recalling over 1.78 million bottles of hypertension treatment tablets from the US and Puerto Rico on account of deviations from current good manufacturing norms, according to a report of the US health regulator.
The US-based arm of Torrent Pharmaceuticals is recalling 133,992 bottles of Losartan Potassium tablets USP in the strength of 25 mg manufactured by the parent company at its Mehsana facility, the Enforcement Report of the USFDA said.
The company is also recalling multiple lots of Losartan Potassium / Hydrochlorothiazide tablets USP 50mg/12.5mg.
In addition, 172,296 bottles of Losartan Potassium / Hydrochlorothiazide tablets, USP 100mg/12.5mg are being recalled, it added.
Torrent Pharmaceuticals Inc is also recalling 173,760 bottles of these tablets in the strength of 100mg/25mg, the enforcement report said.
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.
According to 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".