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
    • 31MAR2023
    • 100mg/vial
    • 50 ml single use vial
    • NDC 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 16, 2023 · Data as of Sep 19, 5:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.