Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50,
Summary
The FDA issued a Class III for Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bou by Aadi Bioscience. Reason: Failed Stability Specifications.
Details
Source
Drug Recall
External ID
D-0059-2023
Action Date
2022-11-23
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50.
Quantity Affected: 2,333 vials
Reason for Recall
Failed Stability Specifications
Distribution
Within the U.S Market - PA, AL, KY, TN
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-13
Company
Pacific Palisades, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 23 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aadi Bioscience) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aadi Bioscience have FDA actions?
This is the only FDA action we have on record for Aadi Bioscience in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0059-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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