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Tiotropium Bromide

FDA recalls

5 rows

Date	Company and reason	Class
Jan 25, 2022	Cardinal Healthcare CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.	Class II · Terminated
Mar 14, 2021	Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Class II · Terminated
Dec 13, 2017	Boehringer Ingelheim Pharmaceuticals, Inc. Failed Stability Specifications	Class II · Terminated
Mar 26, 2014	Boehringer Ingelheim Roxane Inc Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.	Class III · Terminated
Aug 29, 2013	Boehringer Ingelheim Roxane Inc Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler	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).