PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: November 23, 2022 Initiated: October 13, 2022 #D-0059-2023

Product Description

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

Details

Recalling Firm
Aadi Bioscience
Units Affected
2,333 vials
Distribution
Within the U.S Market - PA, AL, KY, TN
Location
Pacific Palisades, CA

Frequently Asked Questions

What product 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.. Recalled by Aadi Bioscience. Units affected: 2,333 vials.
Why was this product recalled?
Failed Stability Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on November 23, 2022. Severity: Low. Recall number: D-0059-2023.