AUDIENCE: Patient, Health Professional, Pharmacy, Immunology ISSUE: As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant. Product Lot Date of Voluntary Withdrawal Expiration Date …
Central Admixture Pharmacy Services (CAPS) Issues Nationwide Recall of Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags Due to Visible Black Particulate Matter in a Single-Sealed Vial
Summary Company Announcement Date: February 24, 2025 FDA Publish Date: February 25, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to visible black particulate matter Company Name: CAPS Brand Name: Brand Name(s) Product Description: Product Description Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag Company…
Beware of Ultraviolet Wands That Give Off Unsafe Levels of UV Radiation
Image Español If you use an ultraviolet wand to disinfect and kill germs — or are thinking about it — be aware that certain brands may produce unsafe levels of radiation and should not be used. The U.S. Food and Drug Administration issued a safety communication warning consumers that certain UV wands may cause injury…
Natural Dior LLC Issues Voluntary Nationwide Recall of Vitafer-L Gold Liquid Due to Presence of Undeclared Tadalafil
Summary Company Announcement Date: February 25, 2025 FDA Publish Date: February 26, 2025 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: Natural Dior LLC Brand Name: Brand Name(s) Natural Dior LLC Product Description: Product Description Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – Natural Dior LLC (USA) – February…
Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems due to Patient Fall Risk from Incorrectly Positioned Mattresses
This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. Affected Product …
Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse due to High Rate of Stroke or Transient Ischemic Attack
This recall involves updating the Instructions for using these devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. Affected Product…
Update on Alert: Solution Set Issue from Baxter Healthcare Corporation
This communication was initially issued as part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. This recall involves removing certain devices from where they are used or sold. The affected products and recommendations…
Update on Alert: Infusion Pump Software Issue from Fresenius Kabi USA
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you…
Early Alert: Infusion Pump Issue from Baxter Healthcare Corporation
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product Sigma Spectrum Infusion System Spectrum IQ Infusion System The FDA…
Endovascular System Recall: Philips Removes and Discontinues Distribution of Tack Endovascular System Due to User Challenges That Caused Additional Procedures to Reposition or Remove Implant
This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: Tack Endovascular System (4F,1.5-4.5mm), 150cm Tack Endovascular System (6F, 3.5 – 6.0mm), 135c Tack…