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Haloperidol Decanoate

FDA recalls

5 rows

Date	Company and reason	Class
Apr 1, 2025	Amerisource Health Services LLC Lack of assurance of sterility. Bacterial contamination detected in some media fill units	Class II · Ongoing
Mar 20, 2025	Somerset Therapeutics Private Limited Lack of Assurance of Sterility: Media fill with bacterial contamination	Class II · Ongoing
Apr 6, 2016	Fresenius Kabi USA, LLC Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.	Class III · Terminated
Feb 17, 2015	Mylan Institutional LLC Lack of Assurance of Sterility; due to leaking vials	Class II · Terminated
Apr 13, 2014	Fresenius Kabi USA LLC Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.	Class III · 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).