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Torrent Pharma remembers about 2.30 lakh bottles of high BP treatment tablets from the USA. UU



Torrent Pharmaceuticals is remembering 2,29,896 bottles of tablets used for high blood pressure treatment of the U.S. UU. And Puerto Rico, due to deviations from the current regulations on the manufacture of goods, as reported by the latest Application Report of the US health regulator.

Torrent Pharma Inc. is recalling 83,016 bottles of Losartan Potassium tablets at the strength of 100 mg, 65,832 bottles at resistance of 50 mg and 43,416 bottles of drugs at resistance of 25 mg, the United States report on Food and Drugs (USFDA) .

The company is also remembering 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 resistance of 50 mg and 12.5 mg.

The tablets were manufactured by Torrent Pharma in its Mehsana facility in India, according to the report.

The reason for the withdrawal is "Detours CGMP: The FDA has confirmed the presence of an impurity, N-Nitrosodimethylamine (NDEA) contained in the API (active pharmaceutical ingredients) used to make the product above the permissible and acceptable daily income level of 0.083 parts per million, "he added.

The voluntary reminder in course in EE. UU. And Puerto Rico is a class II withdrawal, he added.

According to the USFDA, a class II withdrawal begins in a situation where "use or exposure to a violating product can cause temporary or medically reversible adverse effects or when the likelihood of serious adverse health consequences is remote."


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