Summary Company Announcement Date: January 27, 2023 FDA Publish Date: January 28, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Product may contain undeclared egg Company Name: Sovos Brands Intermediate, Inc. Brand Name: Brand Name(s) Product Description: Product Description Soup labeled as Chicken & Gnocchi Company Announcement Sovos Brands Intermediate, Inc….
LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical 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 Name: LifeSPARC System Product Model: LifeSPARC Controller, Model LS-1000 Distribution Dates: December 19, 2019 to November 17, 2022 Devices Recalled in the U.S.: 589 Date Initiated…
David J. Miller and Minnesota Independent Cooperative, Inc., Convicted in Multi-Million-Dollar Prescription Drug Diversion Scheme
Department of JusticeU.S. Attorney’s OfficeNorthern District of California FOR IMMEDIATE RELEASEFriday, January 27, 2023 After two-week trial, federal jury found Miller and his company both guilty of conspiracies involving racketeering, mail and wire fraud, and money laundering, in addition to substantive mail fraud and conspiracy against the United States. SAN FRANCISCO – A federal jury…
Joy Joy’s Bakery Issues Allergy Alert on Undeclared Wheat in Ube Spanish Bread, Ube Ensaymada, and Ube Roll
Summary Company Announcement Date: January 26, 2023 FDA Publish Date: January 26, 2023 Product Type: Food & Beverages Bakery Product/Mix Allergens Reason for Announcement: Recall Reason Description Undeclared Wheat Company Name: Joy Joy’s Bakery Brand Name: Brand Name(s) Joy Joys Bakery Product Description: Product Description Ube Spanish Bread, Ube Ensaymada, and Ube Roll Company Announcement…
Emergent Recalls Certain RSDL (Reactive Skin Decontamination Lotion) Kits Due to Leak Potential
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: Emergent RSDL (Reactive Skin Decontamination Lotion) Kits Product Batch Number: 23005060 Distribution Dates: October 4, 2022 to October 14, 2022 Devices Recalled in the U.S.:…
Almondy is Initiating a Recall of a Limited Quantity of Almondy Chocolate Cake with Daim 14.1oz
Summary Company Announcement Date: January 25, 2023 FDA Publish Date: January 25, 2023 Product Type: Food & Beverages Bakery Product/Mix Foodborne Illness Reason for Announcement: Recall Reason Description Foreign Object Company Name: Almondy Brand Name: Brand Name(s) Product Description: Product Description Chocolate Cake with Daim Company Announcement Almondy is initiating a recall of a limited…
Snack Innovations Inc. Conducts Voluntary Recall on a Limited Quantity of Drizzilicious Mini Rice Cakes 4oz & .74oz and Popcorn 3.6oz Products in the U.S. Due to Undeclared Peanut Allergen on Packaging
Summary Company Announcement Date: January 25, 2023 FDA Publish Date: January 25, 2023 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared peanut allergen Company Name: Snack Innovations, Inc. Brand Name: Brand Name(s) Drizzilicious Product Description: Product Description Mini Rice Cake Bites and Popcorn Company Announcement Snack Innovations…
Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk That Blood May Enter Pump Through Damaged Balloon Catheter, Causing Patient Harm
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: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Product Models: See Medical Device Recall Database entry Distribution Dates: March 6,…
An Ounce of Prevention Is Worth A Pound Of Cure
Image Español The bad news: Heartworm disease can be fatal to dogs, cats, and ferrets. The good news: You can protect your pet from this disease. An ounce of prevention is worth a pound of cure Heartworms can infect your pet year-round and preventing them is much easier, and healthier, for your pet than getting heartworms…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Tecentriq (atezolizumab) for unresectable or metastatic alveolar soft part sarcoma, and Krazati (adagrasib) for KRAS G12C-mutated locally advanced or metastatic non-small cell lung 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 two recent FDA cancer drug approvals. On December 9, 2022, the FDA approved atezolizumab (brand name…