REGULATORY INTELLIGENCE·Recall
Fresenius Kabi USA Recalls 5.3 Million Vials of Ketorolac Tromethamine Due to Particulate Matter
Fresenius Kabi USA, LLC initiated a Class I recall for 5,314,400 vials of Ketorolac Tromethamine Injection, USP, 30 mg per mL, due to particulate matter. This significant event, active from April 2020 to October 2023, posed substantial supply chain risks and patient safety concerns across the USA and Puerto Rico, demanding immediate action from procurement and regulatory teams to ensure continuity of critical injectable pain management therapies.
90-Day Activity