Recalls / Class III
Class IIID-0059-2023
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.
- Brand name
- Fyarro
- Generic name
- Sirolimus
- Active ingredient
- Sirolimus
- Route
- Intravenous
- NDC
- 80803-153
- FDA application
- NDA213312
- Affected lot / code info
- Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50.
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Aadi Bioscience
- Manufacturer
- Aadi Bioscience, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17383 W Sunset Blvd Ste A250, N/A, Pacific Palisades, California 90272-4181
Distribution
- Quantity
- 2,333 vials
- Distribution pattern
- Within the U.S Market - PA, AL, KY, TN
Timeline
- Recall initiated
- 2022-10-13
- FDA classified
- 2022-11-14
- Posted by FDA
- 2022-11-23
- Terminated
- 2023-03-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0059-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.