Strides Pharma recollects over 6 lakh bottles of blood stress therapy tablets in U.S.

The affected lot of blood stress reducing drug tablets have been manufactured by Vivimed Life Sciences in a Tamil Nadu-based plant.

The affected lot of blood stress reducing drug tablets have been manufactured by Vivimed Life Sciences in a Tamil Nadu-based plant.

Strides Pharma Inc. is recalling over six lakh bottles of blood stress reducing drug Losartan Potassium tablets within the US market in a number of strengths as a result of deviation from customary manufacturing norms, in accordance with a USFDA report.

As per the newest enforcement report by the US Meals and Drug Administration (USFDA), the corporate, which is a unit of Bengaluru-headquartered Strides Pharma Science, is recalling 6,78,829 bottles of the blood stress reducing drug within the US market.

The affected lot of tables, in strengths of 25 mg, 50mg and 100 mg, have been manufactured by Vivimed Life Sciences in a Tamil Nadu-based plant and distributed within the US market by New Jersey-based Strides Pharma Inc.

As per the USFDA, the corporate has initiated the Class II recall as a result of “CGMP (present good manufacturing practices) deviations”.

AZIDO impurity ranges noticed to be above acceptable limits, the US well being regulator famous.

As per the USFDA report, Strides Pharma Inc is recalling 2,00,407 bottles of 25 mg Losartan Potassium tablets, 3,81,456 bottles of fifty mg tablets and 96,966 bottles of 100 mg tables, as a part of the nationwide (US) recall, which the corporate initiated on Could 18 this yr.

As per the USFDA, a category II recall is initiated in a state of affairs wherein use of, or publicity to, a violative product might trigger short-term or medically reversible adversarial well being penalties or the place the likelihood of significant adversarial well being penalties is distant.

The US generic drug market was estimated to be round $115.2 billion in 2019. It’s the largest marketplace for pharmaceutical merchandise.

Strides Pharma Science’s international manufacturing websites are situated in India (Chennai, Puducherry and two areas in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the US (New York).

The corporate focuses on “tough to fabricate” merchandise which can be offered in over 100 nations.

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