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…
New Haven Nurse Admits Tampering with and Stealing Lorazepam Vials
Department of JusticeU.S. Attorney’s OfficeDistrict of Connecticut FOR IMMEDIATE RELEASEWednesday, December 11, 2024 Vanessa Roberts Avery, United States Attorney for the District of Connecticut, announced that SEAN FALZARANO, 38, of Southbury, pleaded guilty today before U.S. District Judge Vernon D. Oliver in Hartford to tampering with and stealing Lorazepam vials at the hospital where he…
Kentucky Nurse Pleads Guilty to Opioid Diversion Scheme
Department of JusticeU.S. Attorney’s OfficeDistrict of West Virginia FOR IMMEDIATE RELEASEThursday, December 12, 2024 BECKLEY, W.Va. – Jacqueline Brewster, 54, of Belfry, Kentucky, pleaded guilty on Wednesday, December 11, 2024, to obtaining a controlled substance by fraud and wrongful disclosure of individually identifiable health information. According to court documents and statements made in court, Brewster…
Skip the Antibacterial Soap; Use Plain Soap and Water
Image Español When you buy soaps and body washes, do you reach for products labeled “antibacterial” hoping they’ll keep your family safer? Do you think those products will lower your risk of getting sick, spreading germs or being infected? According to the U.S. Food and Drug Administration, currently there isn’t sufficient evidence to show that…
Early Alert: Infusion Pump Issue from Fresenius Kabi USA
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 Fresenius Kabi USA has…