Sun Pharma recalls 55,000 bottles of generic drug from US market due to manufacturing norms violation

"Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment," the USFDA stated.

The affected lot was produced at Sun Pharma's Dadra-based plant for Memphis-based Northstar Rx LLC, the US regulator noted.

Febuxostat is used to lower uric acid levels in people with gout.

As per the USFDA, the company has initiated the Class II nationwide (US) recall on March 4 this year.

As per the USFDA, a class II recall is initiated in a situation in which the 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.

Sun Pharma is one of the leading generic pharmaceutical companies in the US. The US generic drug market was estimated to be around $115.2 billion in 2019. It is the largest market for pharmaceutical products.