The U.S. branch of India’s Sun Pharma issued a voluntary recall of more than 55,000 bottles of febuxostat tablets used to treat gout after a report of microbial contamination in the company's manufacturing facility.
The Class II recall, which is what the FDA defines as situations that may cause temporary health consequences or a remote chance of serious health outcomes, was initiated on January 18 and covers 55,272 bottles of 40-milligram and 80-milligram dosages, the agency said in an enforcement report.
Febuxostat is prescribed to reduce uric acid levels in patients diagnosed with gout.
The recalled batches were manufactured at Sun Pharma’s Dadra facility In India for Northstar Rx, which is based in Memphis, and distributed nationwide in the U.S.
The regulatory agency said “microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.”
Sun Pharma was most recently in the news for completing its bid to acquire Taro Pharmaceutical that was initiated 17 years ago. In January, Sun agreed to purchase outstanding shares of Israel-based Taro for $43 each, which equated to a value of $348 million and a 48% premium on Taro’s share price of $29.
The company first began courting Taro in 2007 but was rebuffed. A 2012 attempt to take Taro private was also rejected by its shareholders.