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 April 5, 2024, the FDA granted accelerated approval to…
Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic Stainless Steel Debris on the Inside of the Biopsy Needle
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 Product Names: Disposable Biopsy Needles (911933) Product Codes: HAW Lot Number: 837838839 Distribution Dates: August 29, 2023 to January 5, 2024 Devices Recalled in the U.S.: 10…
Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power
Please be aware, this recall is a correction, not a product removal. 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 Product Name: Perseus A500 Product Codes: See Recall Database Entry Devices Recalled in the U.S.:…
DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist
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 Product Names: GeoMed Custom Tracecarts Product Codes: LRO Model Numbers: 53-1829 Laminectomy Tracecart 53-1831 Ortho Total Joint Tracecart 53-1836 General Surgery Tracecart Distribution Dates: August 25, 2022…
Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency
Summary Company Announcement Date: April 23, 2024 FDA Publish Date: April 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Decreased Potency Company Name: Dr. Reddy’s Laboratories Inc Brand Name: Brand Name(s) Dr. Reddy’s Product Description: Product Description Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Company Announcement FOR IMMEDIATE RELEASE Hyderabad India…
Dallas Anesthesiologist Convicted of Tampering with IV Bags Linked to Cardiac Emergencies During Routine Surgeries
Department of JusticeOffice of Public Affairs FOR IMMEDIATE RELEASEFriday, April 12, 2024 A Dallas anesthesiologist was convicted today for injecting dangerous drugs into patient IV bags, leading to one death and numerous cardiac emergencies, the Justice Department announced. Raynaldo Riviera Ortiz Jr., 60, was charged by criminal complaint in September 2023 and indicted the following…
FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication
Date Issued: April 22, 2024 The U.S. Food and Drug Administration (FDA) encourages the public to follow established choking rescue protocols, which are step-by-step guides, approved by the American Red Cross and the American Heart Association to relieve the airway obstruction in choking victims. These rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver)…
Primal Kitchen Issues Voluntary Recall of Primal Kitchen Avocado Oil (750mL Glass) Due to Packaging Issue
Summary Company Announcement Date: April 19, 2024 FDA Publish Date: April 22, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Glass prone to breakage, causing product to spill Company Name: Primal Kitchen Brand Name: Brand Name(s) Primal Kitchen Product Description: Product Description Avocado oil Company Announcement Primal Kitchen is announcing a…
Three Sentenced in International Controlled Substances and Prescription Drug Trafficking Operation
Department of JusticeU.S. Attorney’s OfficeDistrict of Vermont FOR IMMEDIATE RELEASEFriday, April 19, 2024 Burlington, Vermont – The United States Attorney’s Office for the District of Vermont announced that on April 19, 2024, Paul Bateman, 47, a citizen of the United Kingdom who previously resided in Laos, was sentenced in the United States District Court following…
Infinite Herbs, LLC Voluntarily Recalls 2.5-Ounce Fresh Organic Basil Sold From February 1 Through April 6 Because of Possible Health Risk
Summary Company Announcement Date: April 18, 2024 FDA Publish Date: April 19, 2024 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella Company Name: Infinite Herbs LLC Brand Name: Brand Name(s) Infinite Herbs Product Description: Product Description Fresh organic basil Company Announcement FOR IMMEDIATE RELEASE…