Aadi Bioscience recalls Fyarro (sirolimus protein-bound particles for injectable suspension) due to failed stability specifications. This may affect drug safety and efficacy.
Failed Stability Specifications
Aadi Bioscience is recalling Fyarro, a sirolimus injection product, because it failed stability tests. This could mean the drug might not be safe or effective when used as intended.
The product failed stability specifications, which means it may not maintain its intended safety and effectiveness over time. This could lead to potential issues with the drug's performance when administered.
Patients prescribed Fyarro by healthcare providers who received the recalled batch (NDC 80803-153-50, Lot# 6025701) are affected. Those using the product without a healthcare provider's guidance are at higher risk.
Check for the product name 'Fyarro', NDC code 80803-153-50, and lot number 6025701. The expiration date is March 31, 2023.
Identify the NDC code 80803-153-50 and lot number 6025701 on the vial label.
The recall indicates the product failed stability specifications, so it may not be safe or effective. Consult your healthcare provider for guidance.
The recall does not specify a remedy, so contact your healthcare provider for advice on next steps.
The product was manufactured with lot number 6025701, expiring March 31, 2023.
We’ve drafted a message you can send Aadi Bioscience to request your refund or repair — edit it as you like.
Subject: Recall D-0059-2023 — Aadi Bioscience Aadi Bioscience Hello, I own a Aadi Bioscience that is covered by recall D-0059-2023 from Aadi Bioscience. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
