Antifungal Tablets Recalled

Biocon Pharma Inc is recalling 3665 bottles of posaconazole delayed-release tablets after samples of the drug yielded high, out-of-specification degradation results during routine testing, according to the February 15, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 60-count bottles of posaconazole delayed-release tablets, 100 mg (NDC 70377-038-11), from lots BF21003163, BF21003246, and BF21003161 (Exp 9/23); BF21004742 (Exp 12/23); and BF22003359 (Exp 9/25). 

The tablets were manufactured by Biocon Pharma Limited, Bengaluru, India, for Biocon Pharma Inc, Iselin, New Jersey, and were distributed throughout the United States.

Biocon Pharma Inc voluntarily initiated the recall January 31, 2023. On February 14, 2023, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Posaconazole is a prescription antifungal indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients at high risk of developing them.