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Torrent Pharma recalls over 8.82 lakh bottles of hypertension drug from US, Puerto Rico

Press Trust of India  |  New Delhi 

Drug firm is recalling over 8.82 lakh bottles of Potassium tablets, used for treatment of hypertension, from the US and markets on account of deviations from the current good manufacturing norms, according to a report of the US health regulator.

The US-based arm of is recalling 28,464 bottles of Potassium tablets USP in the strength of 25 mg manufactured by the parent company at its in district, the latest Enforcement Report of the the Food and Drug Administration (USFDA) said.

The company is also recalling 164,424 bottles of Potassium tablets, USP, 50 mg from the US and Puerto Rico, the regulator said.

is also recalling 65,184 bottles of tablets, USP, 100 mg from these markets, it added.

The company is recalling 3,31,764 bottles of and Hydrochlorothiazide tablets, USP, 50mg/12.5mg from US and Puerto Rico, the report said.

As many as 54,084 bottles of and Hydrochlorothiazide tablets, USP, 100mg/12.5mg, are also being recalled from these markets, it added.

is also recalling 2,39,016 bottles of Losartan Potassium and Hydrochlorothiazide tablets, USP, 100mg/25mg from the US and

All the ongoing voluntary recalls of the 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.

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the USFDA.

As per the USFDA, a class II recall is initiated in a situation "in which use of, or exposure to, a may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Sun, May 12 2019. 11:35 IST