Novartis Pharmaceuticals SANDIMMUNE Oral Solution recall — FDA D-0144-2024
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Overview of recall records associated with Novartis Pharmaceuticals Corporation, including dates, categories and classifications where available.
Classification mix: Class III: 4, Class II: 1, Class I: 1.
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
This page summarizes recall records in which the official source identifies Novartis Pharmaceuticals Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.