FDAClass IIINovember 23, 2022

Fyarro recall

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

Why was Fyarro recalled?

Failed Stability Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50.

Product
Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi…
Recalling firm
Aadi Bioscience
Quantity
2,333 vials
Distribution
Within the U.S Market - PA, AL, KY, TN
Recall date
November 23, 2022
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls