Fyarro Injection, Powder, Lyophilized, For Suspension
FDA Recall NDC 80803-153
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Fyarro (NDC 80803-153). A significant event, classified as Class III, was initiated on Oct 13, 2022 by Aadi Bioscience, Inc.. The reported reason for this action was: "Failed Stability Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Stability Specifications
Oct 13, 2022
Nov 23, 2022
2,333 vials
Recall Profile & Regulatory Data
Event ID
91019
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Aadi Bioscience
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Within the U.S Market - PA, AL, KY, TN
Termination Date
Mar 16, 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.
Batch or Lot Expiration Information
Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50.
Affected Packages Involved in this Recall
80803-153-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
