American Regent, Inc. Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Class II · Ongoing
Mar 12, 2025
Glenmark Pharmaceuticals Inc., USA CGMP Deviations
Class II · Ongoing
Dec 26, 2021
Padagis US LLC Defective Delivery System
Class II · Terminated
Mar 14, 2021
Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Terminated
Nov 17, 2013
Baxter Healthcare Corp. Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).