Torrent Pharmaceuticals’ arm — Torrent Pharma Inc is recalling 73,896 bottles of hypertension treatment tablets from the US and Puerto Rico on account of deviations from current good manufacturing norms.
The company is also recalling 39,432 bottles of Losartan Potassium tablets, USP in the strength of 100 mg from the US and Puerto Rico. It is also recalling 8,688 bottles of Losartan Potassium/ Hydrochlorothiazide tablets, USP 100mg/25mg. All these recalls in the US and Puerto Rico by Torrent Pharma Inc are ongoing voluntary class II recalls.
The reason for the recalls is CGMP Deviations as 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.
Torrent Pharmaceuticals is Flagship Company of the Torrent group, a leader in cardiovascular and central nervous system segments. It also has presence in gastro-intestinal, diabetology, anti-infective and pain management segments.