Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk That Blood May Enter Pump Through Damaged Balloon Catheter, Causing Patient Harm

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: See Medical Device Recall Database entry Distribution Dates: March 6,…

An Ounce of Prevention Is Worth A Pound Of Cure

Image Español The bad news: Heartworm disease can be fatal to dogs, cats, and ferrets. The good news: You can protect your pet from this disease. An ounce of prevention is worth a pound of cure Heartworms can infect your pet year-round and preventing them is much easier, and healthier, for your pet than getting heartworms…

FDA D.I.S.C.O. Burst Edition: FDA approvals of Tecentriq (atezolizumab) for unresectable or metastatic alveolar soft part sarcoma, and Krazati (adagrasib) for KRAS G12C-mutated locally advanced or metastatic 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 a quick update on two recent FDA cancer drug approvals. On December 9, 2022, the FDA approved atezolizumab (brand name…

SkinnyDipped® Issues Allergy Alert on Undeclared Peanuts in a Limited Number of SkinnyDipped® Dark Chocolate Nut Products

Summary Company Announcement Date: January 20, 2023 FDA Publish Date: January 23, 2023 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared peanut allergen Company Name: SkinnyDipped Brand Name: Brand Name(s) SkinnyDipped Product Description: Product Description Dark Chocolate Cocoa Almond & Dark Chocolate Salted Caramel Cashew Company Announcement…

FDA D.I.S.C.O. Burst Edition: FDA approval of Adstiladrin (nadofaragene firadenovec-vncg) for patients with high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary 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 therapeutic approval. On December 16, 2022, the FDA approved nadofaragene firadenovec-vncg (brand…

FDA D.I.S.C.O. Burst Edition: FDA approval of Lunsumio (mosunetuzumab-axgb) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

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 December 22, 2022, the FDA granted accelerated approval to…

Corim Industries Issues Allergy Alert on Undeclared Peanuts in Peanut Butter Hot Chocolate

Summary Company Announcement Date: January 18, 2023 FDA Publish Date: January 18, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Peanut Allergen Company Name: Corim Industries Brand Name: Brand Name(s) Cocoa de Aroma, Smart Sips and more Product Description: Product Description Peanut butter hot chocolate products Company Announcement January 18,…

Fullei Fresh Issues Correction on Alfalfa Sprout Recall Because of Possible Health Risk

Summary Company Announcement Date: January 17, 2023 FDA Publish Date: January 17, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Contamination with shiga toxin-producing E. coli Company Name: Fullei Fresh Brand Name: Brand Name(s) Fullei Fresh Product Description: Product Description Alfalfa Sprouts Company Announcement MIAMI, FL – Fullei Fresh is voluntarily…

FDA D.I.S.C.O. Burst Edition: FDA approves updated drug labeling including new indications and dosing regimens for Xeloda (capecitabine) tablets under Project Renewal

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 December 14, 2022, the FDA approved updated labeling for…

Northborough Nurse Sentenced for Tampering with Patient’s Liquid Morphine

Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEFriday, January 13, 2023 BOSTON – A registered nurse was sentenced yesterday in federal court in Worcester for tampering with morphine prescribed to a nursing home resident in her care.   Gwen Rider, 43, of Northborough, was sentenced by U.S. Senior District Court Judge Timothy S….