[embedded content] Spanish Many people of all ages take medications. Keeping track of when, how and why you use medications is important for your health and safety. A medication list is a tool to help you keep track of all the prescription medications, over-the-counter (OTC) drugs, vitamins and supplements that you take. Keeping a medication…
FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication
[Posted 1/7/2025] AUDIENCE: Patient, Health Care Professional, Pharmacy, Immunology, Pulmonology ISSUE: FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc. and Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) manufactured by GlaxoSmithKline Biologicals. Specifically, FDA has required each manufacturer to include a new warning…
Dierbregs Markets Issues Allergy Alert on Undeclared Wheat in Product
Summary Company Announcement Date: January 03, 2025 FDA Publish Date: January 07, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared wheat Company Name: Dierbergs Markets Brand Name: Brand Name(s) Dierbergs Kitchen Product Description: Product Description Premium Home-Style Mashed Potatoes Company Announcement Dierbergs is recalling all 16oz Premium Home-Style Mashed…
Abbey Specialty Foods Recalls Wicklow Gold Cheddar Nettle & Chive 5.2 oz and Wicklow Gold Cheddar Tomato & Herb 5.2 oz Because of Possible Health Risk
Summary Company Announcement Date: January 03, 2025 FDA Publish Date: January 03, 2025 Product Type: Food & Beverages Cheese/Cheese Product Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes Company Name: Abbey Specialty Foods Brand Name: Brand Name(s) Wicklow Gold Product Description: Product Description Cheddar style cheeses Company Announcement…
Infusion Pump Battery Recall: ICU Medical Removes Some CSB Batteries Intended For Use With Plum 360, A+, and A+3 Infusion Systems Due to Reports of Allegedly Counterfeit, Untested Batteries In Use
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product and Allegedly Counterfeit Product Product Names: Batteries for use in Plum 360, Plum A+, and…
Early Alert: Fluid Delivery Set Issue from Medline
99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000128741 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000134505 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000133893 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000135769 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000139596 10193489069587 30193489069581…
Braga Fresh Issues Voluntary and Precautionary Advisory Due to Possible Health Risk
Summary Company Announcement Date: December 27, 2024 FDA Publish Date: December 31, 2024 Product Type: Food & Beverages Produce Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Listeria monocytogenes Company Name: Braga Fresh Brand Name: Brand Name(s) Marketside Product Description: Product Description Broccoli Florets Company Announcement Soledad, Calif. – Dec. 27,…
Early Alert: Solution Set Issue from Baxter Healthcare Corporation
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Baxter Healthcare Corporation has…
FDA D.I.S.C.O. Burst Edition: FDA approval of Bizengri (zenocutuzumab-zbco) for Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
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 December 4, 2024, the FDA granted accelerated approval to…
Early Alert: Extracorporeal Blood Circuit Issue from Nuwellis
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Nuwellis has issued a…