Drug firm 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, according to a report of the US health regulator.
The US-based arm of Torrent Pharmaceuticals is recalling 8,688 bottles of Losartan Potassium tablets USP 50 mg, from the US and Puerto Rico, the Enforcement Report of the United States Food and Drug Administration (USFDA) said. It is also recalling 39,432 bottles of Losartan Potassium Tablets, USP in the strength of 100 mg from the US and Puerto Rico, it added.
As per the report, Torrent Pharma Inc is recalling 17,088 bottles of Losartan Potassium /Hydrochlorothiazide tablets, USP 50mg/12.5mg from the same markets. 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, USFDA said.
The reason for the recalls is, “CGMP Deviations: FDA lab confirmed the 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,” it added.
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.”