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Blood thinners

FDA recalls

5 rows

DateCompany and reasonClass
Jul 15, 2026Ascend Laboratories, LLC
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability		Class III · Ongoing
Jun 29, 2026Ascend Laboratories, LLC
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.		Class III · Ongoing
Dec 11, 2024Ascend Laboratories, LLC
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit		Class II · Ongoing
Mar 13, 2023Ascend Laboratories, LLC
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.		Class II · Ongoing
Jan 25, 2022Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.		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).