New Delhi: Drug major Sun Pharma is recalling around 55,000 bottles of a generic medication to treat gout from the American market due to manufacturing practices norms deviations, according to the US health regulator.
The New Jersey-based unit of the Mumbai-based drug major is recalling Febuxostat Tablets in 40 mg and 80 mg strengths, US Food and Drug Administration (USFDA) said in its latest Enforcement Report. 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, it stated. "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.
