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Biocon recalls 5,505 bottles of Simvastatin tablets in US

Date: 21-04-2016

Biocon Inc, part of biotechnology major Biocon, is recalling 5,505 bottles of cholesterol lowering Simvastatin tablets from the US market for being sub-potent. The Class III recall for 5mg tablets of simvastatin pertains to a specific lot manufactured by Blu Caribe, Puerto Rico, USA for Blu Pharmaceuticals, Kentucky, USA (together 'Blu') long before Biocon acquired the simvastatin ANDA from Blu. The FDA notified Biocon as it is the current holders of the ANDA.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.