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…
Gardners Candies Issues Allergy Alert on Undeclared Tree Nuts in Cappuccino Meltaway® Bars and Gardners Meltaway Treat Boxes Containing Cappuccino Meltaway Bars
Summary Company Announcement Date: December 27, 2024 FDA Publish Date: December 27, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared Tree Nuts (Cashews) Company Name: Gardners Candies, Inc. Brand Name: Brand Name(s) Gardners Candies Product Description: Product Description Chocolate Candy Bars Company Announcement Gardners Candies of Tyrone, PA is…
Early Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
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 Olympus has issued a…
Astellas Pharma US, Inc. Issues Voluntary Nationwide Recall of One Lot of PROGRAF® 0.5mg (Tacrolimus) and One Lot of ASTAGRAF XL® 0.5mg (Tacrolimus Extended-Release Capsules) Because Bottles Shipped to U.S. May Contain Empty Capsules
Summary Company Announcement Date: December 23, 2024 FDA Publish Date: December 24, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Bottles may contain empty capsules. Company Name: Astellas Pharma US, Inc. Brand Name: Brand Name(s) Product Description: Product Description Tacrolimus and Tacrolimus Extended-Release capsules Company Announcement FOR IMMEDIATE RELEASE – NORTHBROOK, IL, Dec….
Alcon Laboratories Issues Voluntary Nationwide Recall of One (1) Lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101), Due to Fungal Contamination
Summary Company Announcement Date: December 21, 2024 FDA Publish Date: December 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Fungal Contamination Company Name: Alcon Laboratories Brand Name: Brand Name(s) Product Description: Product Description Lubricant Eye Drugs Company Announcement FOR IMMEDIATE RELEASE – 12/21/2024 – Fort Worth, Texas. Alcon Laboratories is…
Catheter Correction: Boston Scientific Updates Use Instructions for POLARx and POLARx FIT Cryoablation Balloon Catheters due to Higher than Anticipated Number of Reports of Atrio-Esophageal Fistula
This recall involves updating instructions for using devices, and does not involve removing them 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 without following the updated instructions. Affected Product Product Names:…
Dentist Sentenced to 15 Years in Prison for Stealing Drugs from Patients and Performing Surgery Without Proper Pain Management
Department of JusticeU.S. Attorney’s OfficeCentral District of Illinois FOR IMMEDIATE RELEASEFriday, December 20, 2024 SPRINGFIELD, Ill. – A Rochester, Illinois, dentist, Phillip M. Jensen, 64, was sentenced on December 18, 2024, to 15 years in prison for stealing fentanyl from his patients, injecting them with adulterated drugs, and performing surgery without proper pain management. Jenson…