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 (Include the following information) Product Names: Custom Convenience Kits containing the Cardinal Health Monoject Flush Prefilled Syringe including: Leaderflex Insertion Kit with Ultrasound, Insertion Tray-RX, Universal Procedure…
FDA D.I.S.C.O. Burst Edition: FDA approval of Scemblix (asciminib) for patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, previously treated with tyrosine kinase inhibitors, and for adult patients in chronic phase with the T315I mutation
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 October 29, 2021, the FDA granted accelerated approval to…
What Kind of Fish Is That?
FDA research biologist Jonathan Deeds, Ph.D., is working to assure that U.S. seafood is both safe and accurately labeled. DNA from fish such as these are being used as part of a new testing program to enforce the accurate labeling of seafood sold in the U.S. For more photos of this project, available for redistribution,…
Alcohol-based Hand Sanitizer: Drug Safety Communication – Getting in the Eyes Can Cause Serious Injury
[Posted 11/02/2021] AUDIENCE: Consumer, Health Professional, Pharmacy, Pediatrics, Caregivers ISSUE: The FDA is warning that getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in serious injury, including severe irritation and damage to the surface of the eye. Eye exposure to hand sanitizer has been…
Zimmer Biomet Recalls ROSA One 3.1 Brain Application Due to Error in Software
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 ROSA One 3.1 Brain Application Product Codes and Lot Numbers: See Recall Database Entry Devices Recalled in the United States: 119 Distribution Date: December 1, 2019 to…
Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure
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 Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Product Codes and Lot Numbers: See Recall Database Entry Devices Recalled in the United States: 137 battery packs Distribution Date:…
How Long Should You Take Certain Osteoporosis Drugs?
Reduce Your Risk A number of factors put both men and women at risk for osteoporosis, including age, race, family history, and a sedentary lifestyle. But there are also several ways you can reduce that risk, including: getting adequate amounts of calcium and Vitamin D through foods staying physically active, including weight-bearing exercise such as…
artnaturals® Issues Voluntary Recall of Limited Batches of 8oz Bottles of Scent Free Hand Sanitizer Due to Presence of Impurities
Summary Company Announcement Date: October 26, 2021 FDA Publish Date: October 27, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of Impurities Company Name: artnaturals Brand Name: Brand Name(s) artnaturals Product Description: Product Description Scent Free Hand Sanitizer Company Announcement artnaturals is voluntarily recalling ten manufacturing lots of artnaturals 8oz…
Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Cardinal Health’s Monoject™ Flush Prefilled Saline Syringes Placed Into the Following Kits; AMS-9041CP Leaderflex Insertion Kit With Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/S
Summary Company Announcement Date: October 20, 2021 FDA Publish Date: October 27, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for the plunger to draw back after the air has been expelled and reintroduced air back into the syringe Company Name: Windstone Medical Packaging dba Aligned Medical Solutions Brand Name: Brand…
FDA D.I.S.C.O. Burst Edition: FDA approval of Tecentriq (atezolizumab) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA 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 a recent FDA cancer drug approval. On October 15, 2021, the FDA approved atezolizumab (brand name…