Sun Pharma is recalling approximately 55,000 bottles of a generic gout medication from the American market due to deviations from manufacturing practices norms, 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, as reported by the US Food and Drug Administration (USFDA) in its latest Enforcement Report.
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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.
The USFDA said, “Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.”
The affected lot was produced at Sun Pharma’s Dadra-based plant for Memphis-based Northstar Rx LLC.
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Febuxostat is used to lower uric acid levels in people with gout.
The company initiated the Class II nationwide (US) recall on March 4 this year, according to the USFDA. A Class II recall is initiated when the use of a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, as per the USFDA.
This follows Sun Pharma’s recent recall of 54,960 bottles of Mesalamine extended-release capsules in the American market.
Mesalamine delayed-release capsules are indicated for the treatment of mild to moderate ulcerative colitis.
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The affected lot of these capsules were manufactured by Sun Pharmaceutical Industries at its Mohali-based plant and distributed in the US market by Sun Pharmaceutical Industries Inc.
Sun Pharma is one of the leading generic pharmaceutical companies in the US, with the US generic drug market estimated to be around USD 115.2 billion in 2019, making it the largest market for pharmaceutical products.
(Inputs from PTI)
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