Drug 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.
D-0059-2023
Product summary
- Firm
- Aadi Bioscience
- Event
- Event 91019
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,333 vials
- Official record key
drug-enforcement:D-0059-2023
Official wording
Reason: Failed Stability Specifications
Code information: Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50.
Distribution pattern: Within the U.S Market - PA, AL, KY, TN
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications