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Clozapine

FDA recalls

2 rows

DateCompany and reasonClass
Jun 11, 2020Aurobindo Pharma USA Inc.
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Class II · Terminated
Sep 20, 2018Teva Pharmaceuticals USA
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine 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).