Summary Company Announcement Date: January 09, 2023 FDA Publish Date: January 09, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Product discoloration Company Name: Spectrum Laboratory Products Inc. Brand Name: Brand Name(s) Product Description: Product Description Epinephrine bulk API Company Announcement Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline)…
FDA D.I.S.C.O. Burst Edition: FDA approval of Elahere (mirvetuximab soravtansine-gynx) for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal 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 a quick update on a recent FDA cancer drug approval. On November 14, 2022, the FDA granted accelerated approval to…
Should You Give Kids Medicine for Coughs and Colds?
Image Avoid using imported medicines, especially for children. Medications from other countries might not have been evaluated for safety and effectiveness. These products may be addictive or contain other dangerous ingredients. Español Although most colds in children don’t cause serious complications, they can cause stress and worry in parents and caregivers. It’s understandable that you…
Smiths Medical Issues Urgent Medical Device Correction Letter Notifying Customers of Potential Issues with CADD™ Infusion System Infusion Sets for Use with CADD Pumps
Summary Company Announcement Date: December 12, 2022 FDA Publish Date: January 05, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms. Company Name: Smith’s Medical Brand Name: Brand Name(s) Smith’s Medical Product Description: Product Description CADD Infusion System Infusion Sets…
ACTUALIZACIÓN: Se retiran del mercado ciertos ventiladores, máquinas BiPAP y máquinas CPAP de Philips Respironics debido a posibles riesgos para la salud: Comunicado de seguridad de la FDA
English ACTUALIZACIÓN – 22 de diciembre de 2022: La FDA emitió un comunicado de seguridad para proporcionar información adicional a pacientes, cuidadores y proveedores de atención médica sobre dos problemas recientes en ciertos ventiladores Trilogy 100 y Trilogy 200 de Philips Respironics (Philips) reacondicionados. Estos ventiladores Philips Trilogy 100 y Trilogy 2000 fueron retirados del…
Avery’s Savory Popcorn LLC Issues Allergy Alert on Undeclared Allergens in Gourmet Popcorn
Summary Company Announcement Date: December 30, 2022 FDA Publish Date: January 03, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk, soy, peanuts, tree nuts, and sulfites Company Name: Avery’s Savory Popcorn LLC Brand Name: Brand Name(s) Product Description: Product Description Gourmet Popcorn, All Flavors Company Announcement DALLAS, TX, UNITED…
Garden of Light (dba Bakery On Main) Voluntarily Recalls Oat & Honey Organic Granola Due to Potential Almond Contamination
Summary Company Announcement Date: December 30, 2022 FDA Publish Date: December 30, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared almonds Company Name: Garden of Light dba Bakery on Main Brand Name: Brand Name(s) Full Circle Market & Naturally Better Product Description: Product Description Oat & Honey Organic Granola Company…
Daiso Issues Allergy Alert on Undeclared Milk in Tohato Nagewa Snack
Summary Company Announcement Date: December 30, 2022 FDA Publish Date: December 30, 2022 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Daiso California LLC Brand Name: Brand Name(s) Product Description: Product Description Nagewa Snack Company Announcement Daiso California LLC of La Mirada, CA is…
Caesar’s Pasta, LLC Recalls Frozen Manicotti Because of Possible Health Risk
Summary Company Announcement Date: December 29, 2022 FDA Publish Date: December 29, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria monocytogenes Company Name: Caesar’s Pasta, LLC Brand Name: Brand Name(s) Caesar’s Pasta & Orefresco Product Description: Product Description Frozen manicotti Company Announcement Caesar’s Pasta, LLC of Blackwood, NJ is recalling…
SunSprout Enterprises Voluntarily Recalls Two Lots of Alfalfa Sprouts Due to Potential Contamination with Salmonella
Summary Company Announcement Date: December 29, 2022 FDA Publish Date: December 29, 2022 Product Type: Food & Beverages Produce Foodborne Illness Reason for Announcement: Recall Reason Description Salmonella Company Name: SunSprout Enterprises Brand Name: Brand Name(s) Sun Sprouts Product Description: Product Description Alfalfa Sprouts Company Announcement Fremont, Nebraska, December 28, 2022 – SunSprout Enterprises is…