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 two recent FDA cancer drug approvals. On January 27, 2023, the FDA granted accelerated approval to…
Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced – Letter to Health Care Providers
March 1, 2023 The U.S. Food and Drug Administration (FDA) is alerting health care facilities and providers about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohelp system. The disposable part is the HLS Set Advanced that contains the oxygenator, heat exchanger, and integrated centrifugal pump. On February 13, 2023, Getinge/Maquet issued…
Russell Stover Chocolates Issues Allergy Alert on Undeclared Pecan in Sugar Free Peanut Butter Cups
Summary Company Announcement Date: February 28, 2023 FDA Publish Date: February 28, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Pecan Company Name: Russell Stover Chocolates Brand Name: Brand Name(s) Russell Stover Product Description: Product Description Sugar Free Peanut Butter Cups Company Announcement Russell Stover Chocolates of Kansas City, Missouri,…
Lemonland Food Corp Issues Allergy Alert On Undeclared Soy, Wheat, Sesame, Peanut, Walnut, Milk, Crab, Shrimp, Fish (Anchovy, Big Eye Herring, Golden Threadfin Bream, Hairtail, Lizard Fish, Sardine, Pollock) In Multiple Products
Summary Company Announcement Date: February 28, 2023 FDA Publish Date: February 28, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen/ Crustacean Shellfish, Fish, Milk, Peanuts, Soybean, Tree Nuts, Wheat Company Name: Lemonland Food Corp Brand Name: Brand Name(s) No Brand name Listed on Package Product Description: Product…
Lidl Voluntarily Recalls 7 oz Tapas Branded Cocktail Shrimp by Lidl Due to Possible Health Risk
Summary Company Announcement Date: March 01, 2023 FDA Publish Date: March 01, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria monocytogenes Company Name: Lidl US Brand Name: Brand Name(s) Product Description: Product Description Cocktail Shrimp Company Announcement Lidl US has announced a voluntary recall of ready-to-eat Tapas branded Cocktail Shrimp…
FDA D.I.S.C.O. Burst Edition: FDA approval of Trodelvy (sacituzumab govitecan-hziy) for HR-positive breast 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 February 3, 2023, the FDA approved sacituzumab govitecan-hziy (brand…
Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration- Letter to Health Care Providers
February 27, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which feature leaflets externally mounted to the valve frame. Information from published literature…
ACTUALIZACIÓN: Uso del Dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicado de seguridad de la FDA
English ACTUALIZACIÓN – 27 de febrero de 2023 – El 23 de febrero de 2023, la Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) autorizó el Renuvion APR Handpiece para la administración de energía de radiofrecuencia y/o plasma de helio donde se necesita la coagulación/contracción del tejido blando. El…
Kawasho Foods USA Inc. Announces a Voluntary Recall of a Single Lot of GEISHA Medium Shrimp 4oz. Because of Possible Health Risk
Summary Company Announcement Date: February 26, 2023 FDA Publish Date: February 26, 2023 Product Type: Food & Beverages Shellfish Foodborne Illness Reason for Announcement: Recall Reason Description Potential contamination with Clostridium botulinum Company Name: Kawasho Foods USA, Inc. Brand Name: Brand Name(s) Product Description: Product Description GEISHA Medium Shrimp, 4 oz can Company Announcement Kawasho…
Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial Contamination
Summary Company Announcement Date: February 23, 2023 FDA Publish Date: February 24, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to possible microbial contamination Company Name: Global Pharma Healthcare Brand Name: Brand Name(s) Delsam Pharma’s Product Description: Product Description Artificial Eye Ointment Company Announcement FOR IMMEDIATE RELEASE – February 23, 2023, Global…