Drug firm Torrent Pharmaceuticals Inc has recalled over 10.78 lakh bottles of hypertension treatment drugs in light of ‘CGMP Deviations’, the Current Good Manufacturing Practice regulations enforced by US health regulator USFDA.
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 476,340 bottles of Losartan Potassium tablets USP, 50 mg; 121,668 bottles of Losartan Potassium tablets USP, 100 mg and multiple lots of Losartan Potassium / Hydrochlorothiazide tablets USP 50mg/12.5mg, from the market.
In addition, 172,296 bottles of Losartan Potassium / Hydrochlorothiazide tablets, USP 100mg/12.5mg ; and 173,760 bottles of these tablets in the strength of 100mg/25mg, have also been recalled, 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.
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”.