Summary Company Announcement Date: October 24, 2022 FDA Publish Date: October 25, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril Company Name: Aurobindo Pharma USA, Inc. Brand Name: Brand Name(s) Aurobindo Pharma USA, Inc. Product Description: Product Description Quinapril and Hydrochlorothiazide Tablets…
Seed Ranch Flavor Co Issues Allergy Alert on Undeclared Soy in “Umami Everyday Sauce” and “Everything But The Sushi & Dumplings” Sauce
Summary Company Announcement Date: October 23, 2022 FDA Publish Date: October 24, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared soy Company Name: Seed Ranch Flavor Co. Brand Name: Brand Name(s) Seed Ranch Flavor Co. Product Description: Product Description Various sauces Company Announcement Seed Ranch Flavor Co. of Boulder, CO,…
Baxter Issues Urgent Medical Device Correction Regarding Potential Radio Frequency Interference With Other Devices Near Beds Installed With WatchCare System
Summary Company Announcement Date: October 21, 2022 FDA Publish Date: October 24, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for radio frequency (RF) interference with other medical devices. Company Name: Baxter International Inc. Brand Name: Brand Name(s) Product Description: Product Description Incontinence management system Company Announcement Baxter International Inc. announced…
Lo que debe saber sobre el riesgo de Cronobacter en la fórmula infantil en polvo
Image English La Administración de Alimentos y Medicamentos de EE. UU. continúa contribuyendo a garantizar la seguridad de la fórmula infantil en polvo a raíz de los informes de infecciones por Cronobacter sakazakii en cuatro bebés lo que pudo haber contribuido a la muerte de dos pacientes. Esos informes dieron lugar a una investigación de…
Former Kerry Inc. Manager Pleads Guilty in Connection with Insanitary Plant Conditions Linked to 2018 Salmonella Poisoning Outbreak
U.S. Department of Justice FOR IMMEDIATE RELEASEFriday, October 21, 2022 A former quality assurance director for food manufacturer Kerry Inc. pleaded guilty today to charges related to the manufacture of a breakfast cereal linked to a 2018 outbreak of salmonellosis, or Salmonella poisoning. Ravi Kumar Chermala, 47, pleaded guilty to three misdemeanor counts of causing…
Da Cheng Vegetarian Food Inc Issues Allergy Alert on Undeclared Egg Protein in Vegan Drumsticks Expansion
Summary Company Announcement Date: October 19, 2022 FDA Publish Date: October 22, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Egg Protein Company Name: Da Cheng Vegetarian Food Inc. Brand Name: Brand Name(s) Product Description: Product Description Vegan Drumsticks and Vegan Golden Nuggets Company Announcement Da Cheng Vegetarian Food Inc….
Da Cheng Vegetarian Food Inc Issues Allergy Alert on Undeclared Egg Protein in Vegan Drumsticks
Summary Company Announcement Date: October 19, 2022 FDA Publish Date: October 20, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Egg Protein Company Name: Da Cheng Vegetarian Food Inc. Brand Name: Brand Name(s) Product Description: Product Description Vegan Drumsticks Company Announcement Da Cheng Vegetarian Food Inc. of El Monte, CA,…
What to Know About the Risk of Cronobacter in Powdered Infant Formula
Image The U.S. Food and Drug Administration continues to help ensure the safety of powdered infant formula in the wake of reports of Cronobacter sakazakii infections in four infants that may have contributed to death in two patients. Those reports led to an FDA investigation of Abbott Nutrition in Sturgis, Michigan. Insanitary conditions found at…
Former Certified Nurse Practitioner Pleads Guilty to Drug Diversion and Health Care Fraud
Department of JusticeWestern District of Pennsylvania FOR IMMEDIATE RELEASETuesday, October 4, 2022 PITTSBURGH – A resident of Pittsburgh, Pennsylvania, pleaded guilty in federal court to charges of drug diversion and health care fraud, United States Attorney Cindy K. Chung announced today. Larry J. Goisse, Jr., 38, of the City’s Mt. Washington neighborhood, pleaded guilty to six…
Florida Medical Clinic Owners and Staff Charged with Falsifying Clinical Trial Data
U.S. Department of Justice FOR IMMEDIATE RELEASEThursday, October 13, 2022 In an indictment unsealed yesterday, a Miami grand jury charged three defendants for their roles in an alleged scheme to fabricate and falsify clinical drug trial data, the Department of Justice announced. Miguel Montalvo, 52, Bernardo Garmendia, 58, and Ivette Portela, 52, all of Miami,…