FDA recall D-0059-2023

Product

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

Reason for recall

Failed Stability Specifications

Distribution

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

Key facts

Status

Terminated

Initiation date

2022-10-13

Report date

2022-11-23

Termination date

2023-03-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pacific Palisades, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0059-2023