Torrent Pharma has recalled around 2.30 lakh bottles of high BP treatment tablets from the US and Puerto Rico.
These are being recalled on account of deviations from the current goods manufacturing norms, the latest Enforcement Report of the US health regulator has said.
The tablets were manufactured by Torrent Pharma in its Mehsana facility in India, the report said.
Torrent Pharma Inc is recalling 83,016 bottles of Losartan Potassium tablets in the strength of 100 mg, 65,832 bottles in the strength of 50 mg and 43,416 bottles of the drug in the strength of 25 mg, the US Food and Drug Administration (USFDA) report said.
It is also recalling 18,852 bottles of Losartan Potassium and Hydrochlorothiazide tablets in the strength of 100 mg and 12.5 mg, and 18,780 bottles in the strength of 50 mg and 12.5 mg, it added.
The reason behind it is “CGMP Deviations: FDA lab confirmed presence an impurity, N-Nitrosodimethylamine (NDEA) contained in the API (active pharmaceutical ingredients) used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million”, it added.
The ongoing voluntary recall in the US and Puerto Rico is a class II recall, it added.
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”.