Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.

Recall Number: D-0268-2023

Firm: BIOCON PHARMA INC

Classification: Class II

Status: Terminated

Report Date: 20230215

Initiation Date: 20230131

Termination Date: 20240621

Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.

Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.