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Mesalamine
FDA recalls
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Summary of public sources, not medical advice. This page is an automated summary of public information from the FDA, the National Library of Medicine (DailyMed) and CMS Medicare data. It has not been reviewed by a doctor or pharmacist, may be incomplete, out of date or wrong, and does not list every use, dose, warning, interaction or side effect. Do not start, stop or change any medicine, or take a pill you cannot identify, based on this page: ask your doctor or pharmacist and read the official label. In an emergency call 911; for possible poisoning call Poison Control at 1-800-222-1222. Use of this page is subject to our Medical and Data Disclaimer and Terms of Use .
Date Company and reason Class
Feb 4, 2024 Sun Pharmaceutical Industries Inc Failed Dissolution Specifications: Out of specification for dissolution.Class II · Ongoing Jan 17, 2024 Sun Pharmaceutical Industries Inc CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Class II · Completed Oct 27, 2020 Teva Pharmaceuticals USA Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.Class II · Terminated Feb 19, 2020 Teva 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).