Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Stability Specifications
Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
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