D-0059-2023 Class III Terminated
FDA drug recall D-0059-2023 was initiated by Aadi Bioscience on October 13, 2022 and is designated Class III. Reason for recall: Failed Stability Specifications The recall status is terminated (terminated March 16, 2023). Affected quantity: 2,333 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- November 23, 2022
- Initiation Date
- October 13, 2022
- Termination Date
- March 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,333 vials
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.
Reason for Recall
Failed Stability Specifications
Distribution Pattern
Within the U.S Market - PA, AL, KY, TN
Code Information
Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50.