Home / Recalls / BIOCON PHARMA INC / D-0268-2023

D-0268-2023 Class II Terminated

Recalled by BIOCON PHARMA INC — ISELIN, NJ

FDA drug recall D-0268-2023 was initiated by BIOCON PHARMA INC on Jan 31, 2023 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: High Out Of Specification degradation results. The recall status is terminated (terminated Jun 21, 2024). Affected quantity: 3665 bottles.

Recall details

Product Type: Drugs
Report Date: Feb 15, 2023
Initiation Date: Jan 31, 2023
Termination Date: Jun 21, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3665 bottles

Product description

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.

Reason for recall

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

Distribution pattern

Nationwide in the USA

Code information

Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0268-2023
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.