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

FDA recall notice · announced November 23, 2022 · Aadi Bioscience

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Within the U.S Market - PA, AL, KY, TN
Lot/code information: Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50.
Quantity: 2,333 vials
Status: Terminated
Products in this recall event:
- Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA. (D-0059-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.