Biocon recalls 3,665 bottles of Posaconazole Delayed-Release Tablets in US market

20 Feb 2023 Evaluate

Biocon is recalling 3,665 bottles of Posaconazole Delayed-Release Tablets (100 mg, 60-count bottle) in the US market, used to treat serious fungal infections like invasive aspergillosis. USFDA noted that the New Jersey-based Biocon Pharma Inc is recalling the affected lot due to Failed Impurities/Degradation Specifications: High Out Of Specification degradation results. The lot has been manufactured by Biocon Pharma and distributed in the US by Iselin-based Biocon Pharma Inc.

Biocon initiated the Class II nationwide (US) recall on January 31, this year. As per the USFDA, a class II recall is initiated in a situation in which use 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.

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.

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