Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Fresenius SELabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 9 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Fresenius Kabi USA with 339 drug applications, 72 drug recalls, 25 device recalls, 5 complete response letters, 2 510(k) clearances and 1 warning letter. The most recent is a warning letter dated Sep 22, 2026: Warning letter: Aseptic processing, Sterility assurance, Out-of-specification.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 22, 2026 | Warning letter: Aseptic processing, Sterility assurance, Out-of-specificationCDER | Warning letters |
| May 6, 2026 | LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.Class I · Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a | Device recalls |
| May 6, 2026 | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004Class I · Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause d | Device recalls |
| Feb 27, 2026 | Complete response letter, NDA 214610Unapproved | Complete response letters |
| Feb 27, 2026 | Complete response letter, NDA 215818Unapproved | Complete response letters |
| Feb 4, 2026 | The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.Class II · Potential for the Cassette Loading Lever to break. | Device recalls |
| Nov 21, 2025 | Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.Class II · Emphasizing instructions for LVP duration programming located in the IFU. | Device recalls |
| Nov 14, 2025 | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.Class I · Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. | Device recalls |
| Nov 3, 2025 | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.Class II · Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to th | Device recalls |
| Nov 3, 2025 | IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume InfusiClass I · Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury. | Device recalls |
| Sep 3, 2025 | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.Class II · Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen duri | Device recalls |
| Apr 25, 2025 | Complete response letter, NDA 215818Unapproved | Complete response letters |
| Dec 11, 2024 | Complete response letter, NDA 214610Unapproved | Complete response letters |
| May 31, 2023 | Complete response letter, BLA 761275Approved | Complete response letters |
| Dec 4, 2018 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterK180615 · LKN | 510(k) clearances |
| Nov 23, 2016 | AMICUS Separator System, AMICUS Separator System; RefurbishedK162462 · GKT | 510(k) clearances |
| Feb 1, 2013 | CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP PharmacClass III · Labeling: Missing label | Drug recalls |
| Jan 22, 2013 | IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, SchaClass II · Crystallization: Active pharmaceutical ingredient is precipitating in product solution. | Drug recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
