Sun Pharma Recalls Gout Medication: FDA Cites Manufacturing Violations

As per the US health regulator, the US Food and Drug Administration, Indian multinational pharmaceutical company Sun Pharmaceutical Industries Limited is recalling around 55,000 bottles of generic medication to treat gout from the American market due to manufacturing practices norms violations.

Sun Pharma Recalls Gout Medication

According to the recent enforcement report by the US Food and Drug Administration (USFDA), Sun Pharma’s New Jersey-based unit recalls Febuxostat Tablets in 40 mg and 80 mg strengths. Sun Pharmaceutical Industries Inc. is recalling 55,000 bottles of medication, of which 47,520 bottles are of 40mg and 7,488 bottles are of 80 mg. This is due to Current Good Manufacturing Practice (CGMP) regulations deviations. Febuxostat is utilised to lower uric acid levels in individuals with gout.

The United States Food and Drug Administration informed that microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. The affected lot was manufactured at the drug firm’s Dadra-based unit for Memphis-based Northstar Rx LLC.

The regulatory body said that, in March 2024, Sun Pharma initiated the Class II nationwide (US) recall. A class II recall is initiated in the case where the usage 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.

About Sun Pharmaceutical Industries Ltd

Sun Pharmaceutical Industries Ltd is involved in the business of manufacturing, development and marketing a comprehensive range of Active Pharma Ingredients (APIs), and branded and generic formulations. The company and its subsidiaries have several manufacturing facilities located across the world. Sun Pharmaceutical Industries Ltd is the largest pharmaceutical company in India.

Sun Pharmaceutical Industries, Inc. is a wholly-owned subsidiary of Sun Pharmaceutical Industries Ltd. It is one of the top generic pharmaceutical companies in the United States of America. The Active Pharmaceutical Ingredients market in the world has been expanding steadily and is anticipated to grow from US$ 210 billion in 2021 to US$ 292 billion by 2027 at a CAGR of 5.64%.

On March 11, 2024, Monday, the share price of Sun Pharmaceutical Industries Ltd was fluctuating at ₹1,599.80 at 3:00 PM.

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