Drugs & medicalClass I

Fresenius Kabi USA, LLC recalls Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial:…

Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.

Read the official notice →
Date
2022-03-30
Country
United States
Brand
Fresenius Kabi
Product
Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial:…
Classification
Class I
Units
Nationwide USA
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Fresenius Kabi recalls

  1. 2023-12-27
  2. US
    Drugs & medicalClass I

    Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump LVP-0004

    The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of…

    FDA · DeviceFresenius Kabi USA, LLCUS distribution to states of: CA, CO, NJ, UT, and WI.Official notice →
  3. 2023-10-04
  4. US
    Drugs & medicalClass II

    Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital…

    Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber…

    FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of NJ, WI.Official notice →
  5. 2023-04-19
  6. US
    Drugs & medicalClass I

    Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

    Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.

    FDA · DeviceFresenius Kabi USA, LLCDomestic: CA, CO, NJ, WI, & UT. No foreign distribution.Official notice →
  7. 2023-01-25
  8. US
    Drugs & medicalClass II

    Fresenius Kabi USA, LLC recalls Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per…

    Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

    FDA · DrugFresenius Kabi USA, LLCNationwide in the USAOfficial notice →
  9. 2022-10-12
  10. US
    Drugs & medicalClass I

    Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

    The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does…

    FDA · DeviceFresenius Kabi USA, LLCDomestic distribution to NJ and WI.Official notice →
  11. 2021-10-06
  12. US
    Drugs & medicalClass II

    Fresenius Kabi USA LLC recalls Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25…

    Defective container: Cracked vials leading to lack of sterility assurance

    FDA · DrugFresenius Kabi USA LLCU.S.A. NationwideOfficial notice →
All 31 Fresenius Kabi recalls →

Other drugs & medical recalls in the United States

  1. 2022-03-30
  2. US
    Drugs & medicalClass II

    Biomet, Inc. recalls BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which…

    Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of…

    FDA · DeviceBiomet, Inc.Worldwide: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA,…Official notice →
  3. US
    Drugs & medicalClass I

    Philips Respironics, Inc. recalls Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home,…

    In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018…

    FDA · DevicePhilips Respironics, Inc.Global Distribution. US Nationwide.Official notice →
  4. US
    Drugs & medicalClass II

    Philips Healthcare recalls Azurion systems with software release R2.0.x

    In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a…

    FDA · DevicePhilips HealthcareUS Nationwide DistributionOfficial notice →
  5. US
    Drugs & medicalClass II

    Tennessee Technical Coatings, Corp. recalls HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings…

    CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

    FDA · DrugTennessee Technical Coatings, Corp.Distributed in AL, TNOfficial notice →
  6. US
    Drugs & medicalClass I

    Tennessee Technical Coatings, Corp. recalls HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings…

    Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.

    FDA · DrugTennessee Technical Coatings, Corp.Distributed in AL, TNOfficial notice →
  7. US
    Drugs & medicalClass II

    Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg,…

    Super Potent and Failed Reconstitution Time

    FDA · DrugOlympia Compounding Pharmacy dba Olympia PharmacyNationwide in the USA including Puerto Rico.Official notice →
See all drugs & medical recalls →