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Mesalamine

FDA recalls

4 rows

DateCompany and reasonClass
Feb 4, 2024Sun Pharmaceutical Industries Inc
Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Ongoing
Jan 17, 2024Sun Pharmaceutical Industries Inc
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Completed
Oct 27, 2020Teva Pharmaceuticals USA
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Class II · Terminated
Feb 19, 2020Teva Pharmaceuticals USA
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).