Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEWednesday, April 5, 2023 CEO, COO, and Director of Quality Assurance and Regulatory Affairs Charged BOSTON – The former CEO, COO, and Director of Quality Assurance and Regulatory Affairs for Magellan Diagnostics, Inc. (Magellan), a medical device company headquartered in Billerica, Mass., have been charged in…
Karma Spices and Trading Company, LLC Issues Allergy Alert on Undeclared Milk in White Cheddar Cheese Popped Water Lily Seeds
Summary Company Announcement Date: April 05, 2023 FDA Publish Date: April 05, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Karma Spices and Trading Company, LLC Brand Name: Brand Name(s) Product Description: Product Description White Cheddar Cheese Popped Water Lily Seeds Company Announcement Karma Spices and Trading…
Abbott Issues Safety Notification for FreeStyle Libre® Family of Readers in the U.S.
Summary Company Announcement Date: April 03, 2023 FDA Publish Date: April 03, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for battery swelling and overheating. Company Name: Abbott Brand Name: Brand Name(s) Product Description: Product Description Readers in the FreeStyle Libre product family. Company Announcement This communication applies to the Readers…
Wellness Natural USA Inc. Issues Allergy Alert on Undeclared Cashews in SimplyProtein® Peanut Butter Chocolate Crispy Bars
Summary Company Announcement Date: March 31, 2023 FDA Publish Date: April 03, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared tree nuts (cashew) Company Name: Wellness Natural USA Inc. Brand Name: Brand Name(s) SimplyProtein Product Description: Product Description Peanut Butter Chocolate Crispy Bar Company Announcement Wilmington, DE, March 31, 2023…
Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution Due to Presence of Methanol
Summary Company Announcement Date: March 27, 2023 FDA Publish Date: March 28, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of Methanol Company Name: Jarman’s Midwest Cleaning Systems, Inc. Brand Name: Brand Name(s) Midwest Cleaning Solutions, Clean Pro Supply Product Description: Product Description Alcohol Antiseptic 80% Topical Solution Hand Sanitizer…
Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL Due to Potential Bacillus Cereus Contamination in the Product
Summary Company Announcement Date: March 13, 2023 FDA Publish Date: March 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Bacillus cereus Contamination Company Name: Camber Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Device & Drug Safety/Microbial Contamination/Bacillus cereus Company Announcement FOR IMMEDIATE RELEASE – 3/13/2023 – Piscataway, NJ,…
Seven Seas International USA, LLC is Voluntarily Recalling Biltmore Smoked Sockeye Salmon Because of Possible Health Risk
Summary Company Announcement Date: March 14, 2023 FDA Publish Date: March 31, 2023 Product Type: Food & Beverages Fish Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness/Listeria Company Name: Seven Seas International USA, LLC. Brand Name: Brand Name(s) Product Description: Product Description Biltmore Smoked Wild Sockeye Salmon Company Announcement Date: March 14, 2023Sold…
Recall by Datascope/Getinge of Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown After PCBA Communication Loss
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: Distribution Dates: March 6, 2012 to January 13, 2023 Devices…
Judgment Entered Against Fourteen Defendants In Case Dismantling Nationwide Racketeering Conspiracy
Department of JusticeU.S. Attorney’s OfficeNorthern District of California FOR IMMEDIATE RELEASEThursday, March 30, 2023 Latest Tranche of Sentencings Includes Lead Defendants in Drug Diversion Conspiracy SAN FRANCISCO – On Thursday, March 23, 2023, and Friday, March 24, 2023, the federal court entered judgment against fourteen defendants, including cousins and ringleaders Mihran Stepanyan and Artur Stepanyan,…
Oral Surgeon Sentenced to Two Years in Prison for Fentanyl Tampering
Department of JusticeU.S. Attorney’s OfficeSouthern District of Iowa FOR IMMEDIATE RELEASEThursday, March 30, 2023 Des Moines, IA – An Iowa City man was sentenced yesterday to two years in prison for tampering with his dental practice’s fentanyl supply by removing the medication from vials for his own personal use. Dr. Andrew Charles Hartwig, 55, previously…