Department of JusticeU.S. Attorney’s OfficeWestern District of Missouri FOR IMMEDIATE RELEASEThursday, July 13, 2023 At Least 10 Patients Suffered Injury from Treatment with Chinese Products KANSAS CITY, Mo. – The former owner of a Kansas City, Mo., medical spa was sentenced in federal court today for providing illegal treatments to his patients, several of whom…
NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates
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: NOxBOXi Nitric Oxide Delivery System Product Serial Numbers: See Recall Database Entry Distribution Dates: May 21, 2021 to February 27, 2023 Devices Recalled in the…
FDA D.I.S.C.O. Burst Edition: FDA approval of Lynparza (olaparib), with abiraterone and prednisone, for BRCA-mutated metastatic castration-resistant prostate cancer
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 May 31, 2023, the FDA approved olaparib (brand name…
Draeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and Ventilator Stop
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: Oxylog 3000 Plus Emergency and Transport Ventilator Part Numbers: 5704811 and 5704813 Product Material Numbers: See Recall Database Entry Distribution Dates: April 30, 2012 to…
Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients
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 and Codes: Devices Recalled in the U.S.: 21,200 Dates Distributed: March 11, 2021 – May 9, 2023 Date Initiated by Firm: June 1, 2023 Device…
Braga Fresh Issues Precautionary Recall of 365 By Whole Foods Market Brand Organic Asian Inspired Chopped Salad Kit 12oz Bag Due to Potential Presence of Undeclared Allergens
Summary Company Announcement Date: July 11, 2023 FDA Publish Date: July 12, 2023 Product Type: Food & Beverages Prepared Food Allergens Reason for Announcement: Recall Reason Description Undeclared milk and egg allergens Company Name: Braga Fresh Brand Name: Brand Name(s) 365 By Whole Foods Market Product Description: Product Description Potential or Undeclared Allergen – milk…
Betty Lou’s Inc. Issues Allergy Alert on Undeclared (Sesame) in Paleo Java Nuts About Energy Balls With Cacao, Coffee & Pumpkin Seeds
Summary Company Announcement Date: July 10, 2023 FDA Publish Date: July 11, 2023 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared sesame allergen Company Name: Betty Lou’s Inc. Brand Name: Brand Name(s) Betty Lou’s Product Description: Product Description Paleo Java Nuts About Energy Balls with Cacao, Coffee…
UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality – Letter to Health Care Providers
July 11, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers about updated information associated with paclitaxel-coated devices used to treat peripheral arterial disease (PAD). Based on the FDA’s review of the totality of the available data and analyses, we have determined that the data does not support an excess mortality…
Suburban Chicago Businessman Found Guilty of Price Gouging N-95 Masks During Covid-19 Pandemic
Department of JusticeU.S. Attorney’s OfficeNorthern District of Illinois FOR IMMEDIATE RELEASEFriday, June 30, 2023 CHICAGO — The owner of a suburban Chicago medical supply company has been convicted of price gouging customers who sought to purchase scarce N-95 masks amid the Covid-19 pandemic in 2020. KRIKOR TOPOUZIAN, 62, of Winnetka, Ill., was convicted Thursday after…
Las Vegas Man Sentenced for Illegally Selling Steroids Online
Department of JusticeU.S. Attorney’s OfficeWestern District of Missouri FOR IMMEDIATE RELEASEThursday, June 22, 2023 Forfeits $2.7 Million in Money-Laundering Conspiracy KANSAS CITY, Mo. – A Las Vegas, Nevada, man who made millions of dollars by selling illegal steroids online was sentenced in federal court today for his role in a money-laundering conspiracy. Michael R. Breitel,…