Summary Company Announcement Date: December 16, 2024 FDA Publish Date: December 18, 2024 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen – Milk Company Name: Frito-Lay Brand Name: Brand Name(s) Product Description: Product Description Potato Chip Company Announcement PLANO, Texas – December 16, 2024…
Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement – FDA Safety Communication
Date Issued: December 16, 2024 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about the potential need for early device replacement of Boston Scientific Corporation (Boston Scientific) Accolade pacemaker devices, which includes the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and…
Cal Yee Farm LLC Issues Allergy Alert on Undeclared Milk, Soy, Wheat, Sesame, FD&C #6 and Almonds in Snack Products
Summary Company Announcement Date: December 12, 2024 FDA Publish Date: December 14, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen – almond, milk, soy, wheat, sesame, and FD&C #6 Company Name: Cal Yee Farm LLC Brand Name: Brand Name(s) Cal Yee’s, Cal Yee Farm, Boa Vista…
Palermo Villa, Inc. Issues Recall for 1,728 Connie’s Thin Crust Cheese Frozen Pizzas Due to Possible Plastic Contaminant
Summary Company Announcement Date: December 13, 2024 FDA Publish Date: December 13, 2024 Product Type: Food & Beverages Contaminants Reason for Announcement: Recall Reason Description Potential Metal or Chemical Contaminant Company Name: Palermo Villa, Inc Brand Name: Brand Name(s) Connie’s Product Description: Product Description Thin crust cheese frozen pizza, 20.36oz Company Announcement MILWAUKEE – December…
Motivate Me Ashley, LLC is Recalling VidaSlim Brand 90-Day, 30-day and 7-Day Original Root, Root Plus, and Root Capsules & VidaSlim Hot Body Brew Due to the Presence of Yellow Oleander in the Products
Summary Company Announcement Date: December 13, 2024 FDA Publish Date: December 13, 2024 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Product contains toxic yellow oleander. Company Name: Motivate Me Ashley, LLC Brand Name: Brand Name(s) Product Description: Product Description VidaSlim Brand 90-day, 30-day and 7-day Original Root, Root Plus,…
Justice Department Announces Resolution of Criminal and Civil Investigations into McKinsey & Company’s Work with Purdue Pharma L.P.; Former McKinsey Senior Partner Charged with Obstruction of Justice
Department of JusticeOffice of Public Affairs FOR IMMEDIATE RELEASEFriday, December 13, 2024 McKinsey Will Pay $650 Million, Cease Work Relating to Controlled Substances and Implement Significant New Compliance Measures McKinsey & Company Inc. (McKinsey), a global management consulting firm based in New York, has agreed to pay $650 million to resolve a criminal and civil…
Buy-herbal.com Issues Voluntary Nationwide Recall of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules Due to Undeclared Furosemide, Dexamethasone and Chlorpheniramine
Summary Company Announcement Date: December 12, 2024 FDA Publish Date: December 13, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Unapproved Drug Company Name: Buy-herbal.com Brand Name: Brand Name(s) Buy-herbal.com Product Description: Product Description Nhan Sam Tuyet Lien Truy Phong Hoan dietary supplement capsules Company Announcement FOR IMMEDIATE…
Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication – Serious Liver Injury Being Observed in Patients without Cirrhosis
[12/12/2024] AUDIENCE: Gastroenterology, Hepatology, Patient, Health Care Professional, Pharmacy ISSUE: The FDA identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Ocaliva (obeticholic acid) who did not have cirrhosis of the liver. The original clinical trial showed a decrease in alkaline phosphatase (ALP) that supported FDA accelerated approval….
New Age International Recalls ‘Enoki Mushrooms’ Due to Potential Health Risk
Summary Company Announcement Date: December 11, 2024 FDA Publish Date: December 12, 2024 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes. Company Name: New Age International Inc Brand Name: Brand Name(s) Daily Veggies Product Description: Product Description Enoki Mushrooms Company Announcement New Age…
Mississippi Seafood Distributor and Managers Sentenced for Conspiracy and Misbranding Seafood
Department of JusticeU.S. Attorney’s OfficeSouthern District of Mississippi FOR IMMEDIATE RELEASEWednesday, December 11, 2024 Gulfport, MS – A Mississippi seafood distributor and two company managers were sentenced for conspiring with others to mislabel seafood and to commit wire fraud by marketing inexpensive and frozen imported substitutes as more expensive and premium local species. Quality Poultry…