October 2022 FDA Recall Fyarro by Aadi Bioscience
D-0059-2023 - Failed Stability Specifications
This Class III drug recall was voluntarily initiated by Aadi Bioscience on October 13, 2022 for the product Fyarro. The FDA reported the reason for recall as failed stability specifications. The product was distributed in Within the U.S Market - PA, AL, KY, TN and the recall is currently terminated.
Recall Number: D-0059-2023
Failed Stability Specifications
10-13-2022
11-23-2022
2,333 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aadi Bioscience
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Within the U.S Market - PA, AL, KY, TN
03-16-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50.
