Reported Nov 23, 2022 · Terminated
Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50,…
Aadi Bioscience
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aadi Bioscience · 17383 W Sunset Blvd Ste A250 · Pacific Palisades, CA · 90272-4181
Is this the product you have?
- Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA.
- Lot codes and dates
- Lot# 6025701
- Expiration Date
31MAR2023100mg/vial50 ml single use vialNDC 80803-153-50
- Amount recalled
- 2,333 vials
Where it was sold
Why it was recalled
Failed Stability Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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