Department of JusticeU.S. Attorney’s OfficeDistrict of South Dakota FOR IMMEDIATE RELEASEFriday, June 9, 2023 SIOUX FALLS – United States Attorney Alison J. Ramsdell announced that a federal grand jury has indicted a Tea, South Dakota, woman for Tampering with Consumer Products and Obtaining Controlled Substances by Misrepresentation, Fraud, Forgery, Deception, and Subterfuge. Brittany Enstad, age…
Think Before You Ink: Tattoo Safety
Image Español Tattoos are more popular than ever. About 30% of all Americans, and 40% of those aged 18-34 years old, have at least one tattoo, according to polling by the firm Ipsos. While state and local authorities oversee the practice of tattooing, inks and pigments used in tattoos are subject to U.S. Food and…
How Sweet It Is: All About Sweeteners
Image Español Whether it’s to cut down on the number of calories they consume or any of a variety of other reasons, some people choose sweeteners other than sugar. Sweeteners such as aspartame, sucralose, and stevia-derived substances, for example, are widely used ingredients in foods and beverages marketed as “sugar-free” or “diet.” Some of the products…
Oxygenator Devices Used for Extracorporeal Circulation – Letter to Health Care Providers
June 9, 2023 The U.S. Food and Drug Administration (FDA) is providing information to health care providers and facilities on the use of oxygenators in extracorporeal circulation. On May 18, 2023, Getinge/Maquet issued an Urgent Medical Device Removal notice to inform users to not use all Quadrox Oxygenators and certain Getinge/Maquet Venous Hardshell Cardiotomy…
Qué tan dulce es: todo sobre los edulcorantes
Image English Ya sea para reducir la cantidad de calorías que consumen o por cualquier otro motivo, algunas personas eligen edulcorantes diferentes del azúcar. Los edulcorantes como el aspartamo, la sucralosa y las sustancias derivadas de la estevia, por ejemplo, son ingredientes muy utilizados en alimentos y bebidas comercializados como “sin azúcar” o “dietéticos”. Algunos…
Wawona Frozen Foods Voluntarily Recalls Organic Daybreak Blend Processed and Sold in 2022 Due to Possible Health Risk
Summary Company Announcement Date: June 08, 2023 FDA Publish Date: June 09, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Hepatitis A Company Name: Wawona Frozen Foods, Inc. Brand Name: Brand Name(s) Wawona Frozen Foods Product Description: Product Description Organic Daybreak Blend 4lb bags of frozen…
Former Owner of Watauga Recovery Clinics Sentenced to Prison
Department of JusticeU.S. Attorney’s OfficeWestern District of Virginia FOR IMMEDIATE RELEASEWednesday, June 7, 2023 Dr. Ralph Reach to Serve Six Months in Federal Prison to be Followed by 18 Months of Home Detention ABINGDON, Va. – The former owner of a chain of buprenorphine clinics, with locations in Southwest Virginia and Northeast Tennessee, was sentenced…
Regal Health Food International Issues Allergy Alert on Undeclared Peanut in Milk Chocolate Covered Raisins
Summary Company Announcement Date: June 07, 2023 FDA Publish Date: June 08, 2023 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared peanuts. Company Name: Regal Health Food International, Inc. Brand Name: Brand Name(s) Regal Gourmet Snacks Product Description: Product Description Milk Chocolate Raisins Company Announcement Regal Health…
FDA D.I.S.C.O. Burst Edition: FDA approval of Polivy (polatuzumab vedotin-piiq) for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell 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 a quick update on a recent FDA cancer drug approval. On April 19, 2023, the FDA approved polatuzumab vedotin-piiq, brand…
Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support
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: Impella 5.5 with SmartAssist Product Code: 0550-0008 Product Serial Numbers: See Recall Database Entry Distribution Dates: September 28, 2021 to March 6, 2023 Devices Recalled…