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, 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.
(Edits by EP News Bureau)