Aadi Bioscience is recalling 2,333 vials of Fyarro (sirolimus protein-bound particles for injectable suspension) because the product failed to meet stability specifications. This 100 mg injectable treatment is used in clinical settings and was distributed to hospitals, clinics, and specialty pharmacies. No incidents or injuries have been reported to date.
When a medication fails stability testing, its chemical properties may change before its listed expiration date, which could lead to reduced effectiveness or unexpected health risks for patients.
Clinical/Hospital Drug Return
Recall Number: D-0059-2023; Manufactured for Aadi Bioscience, Inc.
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Sources: FDA iRES · Raw API Response
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