FDA recall D-0268-2023

Product

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

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-01-31

Report date

2023-02-15

Termination date

2024-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

ISELIN, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0268-2023