The law defines dietary supplements in part as products taken by mouth that contain a “dietary ingredient.” Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet. Dietary supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids….
Mammography Problems at Madison Avenue Radiology Center 190th Broadway in New York, New York: FDA Safety Communication
Date Issued: August 26, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Madison Avenue Radiology Center 190th Broadway, located in New York, New York, on or after February 26, 2019, about possible problems with the quality of their mammograms. Recommendations for Patients If you have had a more…
FDA D.I.S.C.O. Burst Edition: FDA approval of Welireg (belzutifan) for adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we have a quick update on another recent FDA cancer drug approval. On August 13, 2021, FDA approved belzutifan (brand name Welireg),…
Stop Using Certain N95 Respirators Manufactured by Shanghai Dasheng – Letter to Health Care Providers
August 25, 2021 The U.S. Food and Drug Administration (FDA) is alerting health care facility risk managers, procurement staff, and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co., Ltd. (Shanghai Dasheng). The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health…
FDA D.I.S.C.O. Burst Edition: FDA approval of Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for first-line treatment of adult patients with advanced renal cell carcinoma
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On August 10, 2021, FDA approved the combination of lenvatinib…
Bio-Medical Equipment Service Co. Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Alaris Infusion Pump Module Model 8100 Bezel purchased or installed by Bio-Medical Equipment Service Co. Models: Alaris Model 8100 Product Number: TIPA-8100-4410 Serial Numbers: See Recall Database…
Baxter Issues Urgent Medical Device Correction for All Spectrum IQ Infusion Pumps to Reinforce Important Safety Information Regarding Best Practices for Customer-Initiated IT Network Updates
Summary Company Announcement Date: August 24, 2021 FDA Publish Date: August 24, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Multiple Connectivity Errors Company Name: Baxter International Inc. Brand Name: Brand Name(s) Spectrum IQ Product Description: Product Description Infusion Pumps Company Announcement Baxter International Inc. announced today it has issued an Urgent…
Cardinal Health Recalls Monoject Saline Flush Prefilled Syringes for Risk of Air Re-entering Syringe Leading to Air Embolism
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Monoject Flush Prefilled Syringes (0.9% sodium chloride) Product Codes, All Lots: Product Code (SKU) – Product Description: 8881570121 – 12mL Syringe, 10mL Saline Fill 8881570123 – 12mL…
Cardinal Health Recalls Argyle UVC Insertion Tray Due to Missing Instructions for Use for the Safety Scalpel N11
The FDA identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Argyle UVC Insertion Tray containing Safety Scalpel N11Product Codes: Argyle UVC Insertion Tray (SKU 43201) and Safety Scalpel N11 (vendor part number 73-1811)Manufacturing Dates: August 13,…
Cardinal Health Issues Nationwide Recall of Select Monoject™ Flush Prefilled Saline Syringes
Summary Company Announcement Date: August 19, 2021 FDA Publish Date: August 20, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Products have been found to reintroduce air into the syringe after the air has been expelled Company Name: Cardinal Health Brand Name: Brand Name(s) Product Description: Product Description Flush Prefilled Saline Syringes…