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
Read the official notice →- Date
- 2021-10-06
- Country
- United States
- Brand
- Fresenius Kabi
- Product
- 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…
- Classification
- Class II
- Units
- U.S.A. Nationwide
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2023-12-27
USFresenius 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 →- 2023-10-04
- US
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 → - 2023-04-19
- US
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 → - 2023-01-25
- US
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.
- 2022-10-12
- US
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…
- 2022-03-30
- US
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.
Other drugs & medical recalls in the United States
- 2021-10-06
- US
SigmaPharm Laboratories LLC recalls Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in…
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
- US
- US
Washington Homeopathic Products, Inc. recalls Occular Allergy Blend 87% Alcohol; In Equal Parts of Apis Mellifica 7x Allium Cepa 7x Euphrasia Officinalis 7X Sabadilla…
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- US
Monarch PCM, LLC recalls Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN…
Finished product specification did not meet USP specifications.
- US
American Health Packaging recalls Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American…
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
- US
New Vision Pharmaceuticals LLC recalls CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06…
Subpotent Drug
FDA · DrugNew Vision Pharmaceuticals LLCAL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VAOfficial notice →