Strides Pharma recalls over 6 lakh bottles of blood pressure treatment tablets in the US
Affected lots of blood pressure lowering drugs have been manufactured by Vivimed Life Sciences at a plant in Tamil Nadu.
Affected lots of blood pressure lowering drugs have been manufactured by Vivimed Life Sciences at a plant in Tamil Nadu.
Strides Pharma Inc. is recalling over six lakh bottles of blood pressure lowering drug Losartan Potassium Tablets in the US market due to deviation from standard manufacturing norms, according to a USFDA report.
According to the latest enforcement report by the US Food and Drug Administration (USFDA), the company, which is a unit of Bengaluru-headquartered Strides Pharma Science, is recalling 6,78,829 bottles of the blood pressure lowering drug in the US market.
Affected tablets in 25 mg, 50 mg and 100 mg strengths are manufactured by Vivimed Life Sciences at its Tamil Nadu-based plant and distributed in the US market by New Jersey-based Strides Pharma Inc.
According to the USFDA, the company has initiated a Class II recall due to a “cGMP (Current Good Manufacturing Practices) deviation”.
The US health regulator said AZIDO impurity levels are above acceptable limits.
As part of the nationwide (US) recall, Strides Pharma Inc. is recalling 2,00,407 bottles of 25 mg losartan potassium tablets, 3,81,456 bottles of 50 mg tablets and 96,966 bottles of 100 mg tablets, as part of a nationwide (US) recall, reports the USFDA. Is. The company was started on 18 May this year.
According to the USFDA, a Class II recall is initiated in cases in which temporary or medically reversible adverse health consequences may occur from use of, or exposure to, a contraband product, or where the potential for serious adverse health consequences is very small. Is.
The US generic drug market was worth approximately $115.2 billion in 2019. It is the largest market for pharmaceutical products.
Strides Pharma Science’s global manufacturing sites are located in India (two locations in Chennai, Puducherry and Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the US (New York).
The company focuses on “hard to manufacture” products that are sold to over 100 countries.