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Class III: unlikely to cause harmTerminated

Aadi Bioscience Fyarro Recall

Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 10…

Aadi Bioscience · Pacific Palisades, CA

Risk level
Class III
Reported by FDA
Nov 23, 2022
Recall ID
D-0059-2023
Check your lot numberHow we source this data

Summary

Aadi Bioscience recalled Fyarro starting Oct 13, 2022. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0059-2023 on Nov 23, 2022. Reason: Failed Stability Specifications. Status: Terminated.

Why it was recalled

Failed Stability Specifications

Product description

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 numbers, UPCs & expiration codes

Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50.

Where it was sold

Within the U.S Market - PA, AL, KY, TN

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0059-2023
Classification
Class III
Status
Terminated
Recall initiated
Oct 13, 2022
FDA report date
Nov 23, 2022
Quantity
2,333 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Aadi Bioscience

Original FDA data

Every field from FDA enforcement report D-0059-2023, exactly as published.

Show all FDA fields
City
Pacific Palisades
State
CA
Status
Terminated
Country
United States
Event ID
91019
Address
17383 W Sunset Blvd Ste A250
Code information
Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50.
Postal code
90272-4181
Report date
Nov 23, 2022
Product type
Drugs
Recall number
D-0059-2023
Classification
Class III
Recalling firm
Aadi Bioscience
Product quantity
2,333 vials
Termination date
Mar 16, 2023
Reason for recall
Failed Stability Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA.
Distribution pattern
Within the U.S Market - PA, AL, KY, TN
Recall initiation date
Oct 13, 2022
Initial firm notification
Letter
Center classification date
Nov 14, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0059-2023, published Nov 23, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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