NEW DELHI: The AZIDO impurity levels in the Losartan Potassium tablets were observed to be above acceptable limits, the US health regulator noted.
The affected lot of blood pressure lowering 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 pressure lowering drug Losartan Potassium tablets in the US market in multiple strengths due to deviation from standard manufacturing norms, according to a USFDA report.
As per 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.
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 in the US market by New Jersey-based Strides Pharma Inc.
As per the USFDA, the company has initiated the Class II recall due to “CGMP (current good manufacturing practices) deviations”.
AZIDO impurity levels observed to be above acceptable limits, the US health regulator noted.
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 50 mg tablets and 96,966 bottles of 100 mg tables, as part of the nationwide (US) recall, which the company initiated on May 18 this year.
As per 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.
The US generic drug market was estimated to be around $115.2 billion in 2019. It is the largest market for pharmaceutical products.
Strides Pharma Science’s global manufacturing sites are located in India (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the US (New York).
The company focuses on “difficult to manufacture” products that are sold in over 100 countries. —PTI