Department of JusticeDistrict of Massachusetts FOR IMMEDIATE RELEASEFriday, June 24, 2022 BOSTON – A former Massachusetts emergency medical technician (EMT) paramedic has been charged in connection with tampering with liquid fentanyl vials at the ambulance company at which she worked. Candice Mangan, 41, of Medford, was charged with tampering with a consumer product. She will appear…
Draeger, Inc Recalls SafeStar 55 Breathing System Filters for Possible Obstructions That May Block Oxygen Flow 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 Name: SafeStar 55 Breathing System Filter Product Model Numbers: MP01790 Lot Number: LT2103 Devices Recalled in the U.S.: 35,950 Dates distributed: August 18, 2021, to October…
UPDATE on Type III Endoleaks Associated with Endovascular Graft Systems – Letter to Health Care Providers
On October 28, 2019, the FDA issued a Safety Communication to provide an update on Type III Endoleaks Associated with Use of Endologix AFX Endovascular AAA Graft Systems. October 15, 2018 – The FDA has issued a Class I recall to notify patients and health care providers about the risk of Type III endoleaks with…
BD Announces Voluntary Recall on Intraosseous Products
Summary Company Announcement Date: June 22, 2022 FDA Publish Date: June 22, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries Company Name: BD Brand Name: Brand Name(s) Product Description: Product…
Four People Charged in Multimillion-Dollar Health Care Fraud Scheme to Defraud Amtrak
Department of JusticeDistrict of New Jersey FOR IMMEDIATE RELEASEThursday, June 23, 2022 NEWARK, N.J. – Three men and one woman were arrested today for participating in a health care fraud scheme to defraud Amtrak by bribing Amtrak employees to allow people to submit fraudulent claims to the Amtrak health insurance plan, U.S. Attorney Philip R. Sellinger…
Former CEO of Drug Manufacturing Company Pleads Guilty to Conspiring to Defraud the FDA and Distributing Adulterated Drugs
Department of JusticeSouthern District of Florida FOR IMMEDIATE RELEASEFriday, June 24, 2022 Miami, Florida – Raidel Figueroa, the former CEO and co-owner of Pharmatech, LLC, a drug and dietary supplement manufacturer that operated in Broward County, Florida, pled guilty to conspiring to defraud the FDA, falsifying records in an FDA investigation, obstructing proceedings before the FDA,…
Blount Fine Foods Voluntarily Recalls a Limited Amount (a Single Lot) of Southwest Corn Chowder Due to Undeclared Wheat Allergen
Summary Company Announcement Date: June 24, 2022 FDA Publish Date: June 24, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared wheat allergen Company Name: Blount Fine Foods Brand Name: Brand Name(s) Panera at Home Product Description: Product Description Southwest Corn Chowder Company Announcement FALL RIVER, MA (June 24, 2022) –…
Medtronic Recalls HeartWare HVAD System Batteries Due to Battery Failure
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: Medtronic HVAD Batteries Product Codes: See Recall Database Entry Model Number: 1650DE Manufacturing Dates: April 13, 2021 to April 19, 2021 Distribution Dates: April 20,…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line advanced or metastatic esophageal squamous cell carcinoma, and Kymriah (tisagenlecleucel) for relapsed or refractory follicular lymphoma
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 another quick update on two recent FDA cancer drug approvals. On May 27, 2022, the FDA approved the following for…
Amherst County Veterinarian Sentenced for Opioid Theft
Department of JusticeWestern District of Virginia FOR IMMEDIATE RELEASEFriday, June 22, 2022 LYNCHBURG, Va. – A former veterinarian, who admitted to stealing opioids, was sentenced today to eight months in federal prison. Patrick Gries, 54, of Madison Heights, Virginia, pleaded guilty in January 2022 to one count of adulteration of a drug held for sale after…