Department of JusticeSouthern District of Florida FOR IMMEDIATE RELEASEWednesday, October 19, 2022 MIAMI – A federal judge sentenced two Florida women to prison in connection with their participation in a conspiracy to falsify clinical trial data. Senior U.S. District Judge Donald L. Graham of the Southern District of Florida sentenced Analay Rico, 37, of Fort Lauderdale,…
Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices
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 Names: Amara View Full Face Mask DreamWisp Nasal Mask DreamWear Full Face Mask Wisp and Wisp Youth Nasal Mask Therapy Mask 3100 NC/SP Serial and Model…
Albertsons Companies Voluntarily Recalls Chicken Salad Products Due to an Undeclared Allergen
Summary Company Announcement Date: October 18, 2022 FDA Publish Date: October 19, 2022 Product Type: Food & Beverages Prepared Food Allergens Reason for Announcement: Recall Reason Description Undeclared Tree Nuts (Cashews) Company Name: Albertsons Companies Brand Name: Brand Name(s) Ready Meals and Safeway Inc. Product Description: Product Description Chicken Salad Quad & Chicken Salad Sandwich…
FDA D.I.S.C.O. Burst Edition: FDA approval of Pedmark (sodium thiosulfate) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors
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 September 20, 2022, the FDA approved sodium thiosulfate (brand…
Nestlé USA Announces Voluntary Recall of NESTLÉ® TOLL HOUSE® STUFFED Chocolate Chip Cookie Dough with Fudge Filling Products Due to Potential Presence of Foreign Material
Summary Company Announcement Date: October 13, 2022 FDA Publish Date: October 17, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Foreign Object Company Name: Nestle USA Brand Name: Brand Name(s) NESTLÉ® TOLL HOUSE® Product Description: Product Description STUFFED Chocolate Chip Cookie Dough with Fudge Filling Company Announcement ARLINGTON, VA., October 13,…
Hammond’s Candies Issues Allergy Alert on Undeclared Peanut in Salted Caramel Cookies
Summary Company Announcement Date: October 17, 2022 FDA Publish Date: October 17, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Peanuts Company Name: Hammond’s Candies Brand Name: Brand Name(s) Hammond’s Product Description: Product Description Salted Caramel Cookies Company Announcement Hammond’s Candies of Denver, CO is recalling 5-ounce boxes of Hammond’s…
FDA D.I.S.C.O. Burst Edition: FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract 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 September 2, 2022, FDA approved durvalumab (brand name Imfinzi)…
Abbott Voluntarily Recalls Certain Lots of 2 Fl. Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. Infant Formula Supply
Summary Company Announcement Date: October 14, 2022 FDA Publish Date: October 14, 2022 Product Type: Food & Beverages Infant Formula & Foods Reason for Announcement: Recall Reason Description Potential for spoilage Company Name: Abbott Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Ready-to-feed liquid products for infants and children Company Announcement Abbott…
Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton Due to Vial Breakage
Summary Company Announcement Date: October 12, 2022 FDA Publish Date: October 13, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Vial Breakage Company Name: Exela Pharma Sciences, LLC Brand Name: Brand Name(s) Exela & Civica Product Description: Product Description Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial Company Announcement FOR IMMEDIATE RELEASE…
Craftology, LLC DBA Dutch Treat Foods Issues Allergy Alert on Undeclared Cashews in “Craftology This is My Happy Place Pasta Salad”
Summary Company Announcement Date: October 11, 2022 FDA Publish Date: October 12, 2022 Product Type: Food & Beverages Prepared Food Allergens Reason for Announcement: Recall Reason Description Undeclared cashews Company Name: Craftology, LLC dba Dutch Treat Foods Brand Name: Brand Name(s) Craftology Product Description: Product Description Pasta Salad Company Announcement Craftology, LLC dba Dutch Treat…