Sun Pharma Recalls 55,000 Bottles of Generic Drug in the US Market

11 Mar 2024 , 10:14 AM

Sun Pharma is recalling around 55,000 bottles of a generic gout drug from the American market owing to violations in manufacturing standards requirements, according to the US health agency. The New Jersey-based business of the Mumbai-based pharmaceutical company is recalling Febuxostat Tablets in 40 mg and 80 mg strengths, according to the US Food and Drug Administration’s (USFDA) most recent Enforcement Report.

Sun Pharmaceutical Industries Inc is recalling 47,520 bottles (40mg) and 7,488 bottles (80 mg) of the drug owing to deviations from Current Good Manufacturing Practice requirements (CGMP), the company noted.

The USFDA reported microbial contamination in standing water within the duct of the manufacturing equipment,” the regulatory body highlighted.

The impacted batch was manufactured at Sun Pharma’s Dadra facility for Northstar Rx LLC based in Memphis, as noted by the US regulator.

Febuxostat is a medication used to reduce uric acid levels in persons who have gout. According to the USFDA, the corporation launched the Class II countrywide (US) recall on March 4, this year.

According to the USFDA, a class II recall is launched when the use or exposure to a violative product may result in transitory or medically recoverable adverse health effects, or when the likelihood of substantial adverse health consequences is low.

Sun Pharma is one of the top generic pharmaceutical businesses in the United States. The US generic medication industry was predicted to be worth around USD 115.2 billion in 2019. It is the largest market for pharmaceuticals.

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