Sun Pharma’s arm recalls around 55,000 bottles of generic drug from US market

11 Mar 2024 Evaluate

Sun Pharmaceutical Industries’ subsidiary -- Sun Pharmaceutical Industries Inc.is recalling around 55,000 bottles of a generic medication to treat gout from the American market due to manufacturing practices norms deviations. The New Jersey-based unit of the Mumbai-based drug major is recalling Febuxostat Tablets in 40 mg and 80 mg strengths.
Sun Pharmaceutical Industries Inc is recalling 47,520 bottles (40mg) and 7,488 bottles (80 mg) respectively of the medication due to Current Good Manufacturing Practice regulations (CGMP) deviations.

The affected lot was produced at Sun Pharma's Dadra-based plant for Memphis-based Northstar Rx LLC. Febuxostat is used to lower uric acid levels in people with gout. As per the US Food and Drug Administration (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 Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

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