Summary Company Announcement Date: December 06, 2022 FDA Publish Date: December 06, 2022 Product Type: Food & Beverages Chocolate/Cocoa Product Allergens Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen/Peanut Company Name: Cranberry Sweets & More Brand Name: Brand Name(s) Cranberry Sweets Product Description: Product Description Mint Meltaways Company Announcement December 6, 2022, Cranberry…
FDA D.I.S.C.O. Burst Edition: FDA approval of Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for non-small cell lung cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on a recent FDA cancer drug approval. On November 8, 2022, the FDA approved cemiplimab-rwlc (brand name…
UPDATE: Impella RP System Post-Approval Study Results and Updated Labeling – Letter to Health Care Providers
December 5, 2022 The U.S. Food and Drug Administration (FDA) is issuing this update to our previous letter to health care providers to inform the health care community of the final post-approval study (PAS) results and updated labeling for the Impella RP System manufactured by Abiomed. The final PAS results show that the survival rate…
Exportadora Copramar Recalls James Farms Frozen Raspberries Due to Possible Health Risk
Summary Company Announcement Date: December 03, 2022 FDA Publish Date: December 03, 2022 Product Type: Food & Beverages Fruit/Fruit Product Foodborne Illness Reason for Announcement: Recall Reason Description Hepatitis A Company Name: Exportadora Compramar Brand Name: Brand Name(s) James Farms Product Description: Product Description Frozen Raspberries Company Announcement Exportadora Copramar is recalling 1260 cases of…
Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) Shortage – Letter to Health Care Providers
December 2, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care facilities and providers of a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP parts. Recommendations The FDA recommends that health care facilities and providers who use Getinge Maquet/Datascope…
Former Vice President and General Manager of New England Compounding Center Sentenced to Prison
Department of JusticeDistrict of Massachusetts FOR IMMEDIATE RELEASEThursday, December 1, 2022 BOSTON – A former co-owner of the now-defunct New England Compounding Center (NECC) was sentenced today in federal court in Boston in connection with conspiring to defraud the Food and Drug Administration (FDA). Gregory Conigliaro, 57, of Southborough, Mass. was sentenced by U.S. District Court…
Comunicado de seguridad de la FDA: reutilice las cánulas de traqueostomía o cambie a alternativas adecuadas durante su escasez
Fecha de emisión: 31 de octubre de 2022 La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) está alertando a los pacientes, cuidadores y proveedores de atención médica acerca de una escasez de cánulas de traqueostomía, incluidas las cánulas de traqueostomía Bivona fabricadas por ICU Medical. Es más probable que la escasez de…
Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to Vial Breakage UPDATED November 28, 2022
Summary Company Announcement Date: November 28, 2022 FDA Publish Date: November 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Vial Breakage Company Name: Exela Pharma Sciences, LLC Brand Name: Brand Name(s) Product Description: Product Description Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial Company Announcement FOR IMMEDIATE RELEASE – November 28,…
Rocky Mountain Pies, LLC Issues Allergy Alert on Undeclared (Tree Nuts Almonds) in Red Button Vintage Creamery 31.88 oz French Silk Pie
Summary Company Announcement Date: November 29, 2022 FDA Publish Date: November 29, 2022 Product Type: Food & Beverages Bakery Product/Mix Allergens Reason for Announcement: Recall Reason Description Undeclared almond Company Name: Rocky Mountain Pies, LLC Brand Name: Brand Name(s) Red Button Vintage Creamery Product Description: Product Description French Silk Pie Company Announcement Rocky Mountain Pies,…
Doctor Pleads Guilty to Using Misbranded and Adulterated Products Sold as Botox and Juvederm
U.S. Department of Justice FOR IMMEDIATE RELEASEMonday, November 28, 2022 A San Francisco-area doctor pleaded guilty on Nov. 22 in connection with the use of unapproved products she sold as genuine Botox and Juvederm. Dr. Lindsay Clark, 45, pleaded guilty to one misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by receiving…