Aadi Bioscience recalls Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50,…

Recall date

October 13, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0059-2023

FDA classification

Class III

Brand / firm

Aadi Bioscience

Sold / distributed

Within the U.S Market - PA, AL, KY, TN

Why it was recalled

Failed Stability Specifications

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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