Date Issued: July 15, 2021 The U.S. Food and Drug Administration (FDA) is informing patients, their caregivers, and health care providers of potential mechanical failures and concerns about tissue incompatibility (biocompatibility) associated with components of the following NuVasive Specialized Orthopedics’ MAGEC devices: MAGEC Spinal Bracing and Distraction System MAGEC 2 Spinal Bracing and Distraction System MAGEC…
Nitrite “Poppers”
Image Health care providers are reporting increases in deaths and hospitalizations related to intentional ingestion or inhalation of nitrite products for recreational use, including sexual experience enhancement.Commonly referred to as “poppers,” these products contain chemical substances similar to the prescription medication, amyl nitrite, which is prescribed for the relief of chest pain. However, poppers have…
5000 Years Foods, Inc. Recall Cabbage Kimchi Because of Possible of Health Risk
Summary Company Announcement Date: July 13, 2021 FDA Publish Date: July 14, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential Listeria monocytogenes contamination Company Name: 5000 Years Foods, Inc. Brand Name: Brand Name(s) 5000 Years Foods, Inc. Product Description: Product Description Kimchi Products Company Announcement 5000 YEARS FOODS, INC. of…
Johnson & Johnson Consumer Inc. Issues Voluntary Recall of Specific NEUTROGENA® and AVEENO® Aerosol Sunscreen Products Due to the Presence of Benzene
Summary Company Announcement Date: July 14, 2021 FDA Publish Date: July 14, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Testing identified low levels of benzene Company Name: Johnson & Johnson Brand Name: Brand Name(s) Neutrogena, Aveeno Product Description: Product Description Company Announcement Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all…
St. Jude Agrees to Pay $27 Million for Allegedly Selling Defective Heart Devices
U.S. Department of Justice FOR IMMEDIATE RELEASEThursday, July 8, 2021 St. Jude Medical Inc. (St. Jude) has agreed to pay $27 million to settle allegations under the False Claims Act that, between November 2014 and October 2016, it knowingly sold defective heart devices to health care facilities that, in turn, implanted the devices into patients…
Lexington Doctor and Wife Charged in Superseding Indictment in International Money Laundering and Health Care Fraud Scheme
Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEThursday, July 8, 2021 BOSTON – A Lexington doctor and his wife, who works as his office manager, were charged today in a superseding indictment in connection with an international money laundering scheme involving importing illegal, misbranded drugs. Rahim Shafa, 64, was indicted on health care…
Former Owner of Defunct New England Compounding Center Resentenced to 14 Years in Prison in Connection with 2012 Fungal Meningitis Outbreak
Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEWednesday, July 7, 2021 Outbreak was the largest public health crisis ever caused by a contaminated pharmaceutical drug BOSTON – The former owner of the now-defunct New England Compounding Center (NECC) was resentenced today in federal court in Boston in connection with the 2012 nationwide fungal…
Avanos Medical Inc. to Pay $22 Million to Resolve Criminal Charges Related to the Fraudulent Misbranding of Its Microcool Surgical Gowns
U.S. Department of Justice FOR IMMEDIATE RELEASEThursday, July 8, 2021 Avanos Medical Inc. to Pay $22 Million to Resolve Criminal Charges Related to the Fraudulent Misbranding of Its Microcool Surgical Gowns Avanos Medical Inc., a U.S.-based multinational medical device corporation, has agreed to pay more than $22 million to resolve a criminal charge relating to…
LSG Sky Chefs Recalls Circle K Brand Chicken Salad Sandwich Because of Possible Health Risk
Summary Company Announcement Date: July 07, 2021 FDA Publish Date: July 08, 2021 Product Type: Food & Beverages Prepared Food Foodborne Illness Reason for Announcement: Recall Reason Description Potential Listeria monocytogenes contamination Company Name: LSG Sky Chefs Brand Name: Brand Name(s) Product Description: Product Description Chicken Salad Sandwich Company Announcement LSG Sky Chefs announced today…
Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers
July 8, 2021 The U.S. Food and Drug Administration (FDA) is informing health care providers about potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. The FDA is also providing health care providers with recommendations for monitoring patients with these devices, which include the following: Stainless Steel (Biodur…