Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA.

Recall Number: D-0059-2023

Firm: Aadi Bioscience

Classification: Class III

Status: Terminated

Report Date: 20221123

Initiation Date: 20221013

Termination Date: 20230316

Failed Stability Specifications

Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA.