Drug firm Torrent Pharma Inc. is recalling 73,896 bottles of hypertension treatment tablets from the U.S. and Puerto Rico on account of deviations from current “good manufacturing” norms, according to a report of the U.S. Food and Drug Administration.
The U.S.-based arm of Torrent Pharmaceuticals Ltd. is recalling 8,688 bottles of Losartan Potassium tablets USP 50 mg, from the U.S. and Puerto Rico, the Enforcement Report of the U.S. FDA said.
It is also recalling 39,432 bottles of Losartan Potassium tablets, USP in the strength of 100 mg from the U.S. and Puerto Rico, it added.
As per the report, Torrent Pharma 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 U.S. and Puerto Rico by Torrent Pharma are ongoing voluntary class II recalls, U.S. FDA said.
The reason for the recalls is, “Current Goods Manufacturing Practices 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,” it added.
As per the U.S. FDA, 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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