Biocon Recalls 3,665 Bottles Of Antifungal Drug In US For "Failed Specifications"

The US health regulator said that the Bengaluru-based firm is recalling 3,665 bottles of Posaconazole Delayed-Release Tablets

Biotechnology major Biocon is recalling 3,665 bottles of antifungal medication in the US market for “failed degradation specifications”, according to the US Food and Drug Administration (USFDA).

In its latest Enforcement Report, the US health regulator said that the Bengaluru-based firm is recalling 3,665 bottles of Posaconazole Delayed-Release Tablets (100 mg, 60-count bottle), 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, it added.

Biocon initiated the Class II nationwide (US) recall on January 31, this year.