October 13, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor the risk of Nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using heater-cooler devices, and to collaborate with stakeholders including public health partners, manufacturers, and experts to evaluate additional strategies to reduce the risk of infection from using these…
Eating Too Much Salt? Ways to Cut Back…Gradually
[embedded content] Español Did you know that “salt” and “sodium” are not the same thing, even though they’re often used interchangeably? Sodium, a mineral, is one of the elements found in salt. Salt is where most of your sodium comes from. The U.S. Food and Drug Administration is working to make sure people have greater…
Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency
Summary Company Announcement Date: October 12, 2021 FDA Publish Date: October 12, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Super Potent Company Name: Teligent Pharma, Inc. Brand Name: Brand Name(s) Teligent Pharma, Inc. Product Description: Product Description Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) Company Announcement Buena, NJ, Teligent Pharma, Inc….
Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication
Date Issued: October 5, 2021 The U.S. Food and Drug Administration (FDA) is alerting test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue. For these tests, a “false positive” is a test…
Do Not Use Needle-Free Devices for Injection of Dermal Fillers – FDA Safety Communication
Date Issued: October 8, 2021 The U.S. Food and Drug Administration (FDA) is warning the public and health care professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid (HA) or other lip and facial fillers, collectively and commonly referred to as dermal fillers or fillers. The FDA is aware…
DeRoyal Industries, Inc. Recalls Procedure Packs Containing Smiths Medical NORMOFLO Irrigation Warming Set Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers
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: DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set Product Codes for CYSTO Pack PGYBK/89-5721.03 and GU TUR BASIN SET PGYBK/89-6425.07: See Recall Database…
UPDATE: Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers
October 7, 2021 The U.S. Food and Drug Administration (FDA) is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with surgical staplers and staples for internal use. In addition, we are announcing new actions we are taking to help ensure the safe use…
Imperative Care Inc. Recalls ZOOM 71 Reperfusion Catheter Due to Risk of Breaks During Use
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 ZOOM 71 Reperfusion Catheter Product Codes and Lot Numbers: See Recall Database Entry Devices Recalled in the United States: 3,098 Distribution Date: September 23, 2020 to August…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and Jakafi (ruxolitinib) for chronic graft-versus-host disease after failure of one or two 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 two recent FDA cancer drug approvals. On September 20, 2021, the FDA approved tisotumab vedotin-tftv (brand…
Medtronic Recalls Remote Controllers Used with Paradigm and 508 MiniMed Insulin Pumps for Potential Cybersecurity Risks
October 5, 2021 Update: Medtronic has expanded this recall of remote controllers used with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to potential cybersecurity risks. Medtronic sent updated instructions to people who use these devices, including instructions to stop using and return the remote controller. If you…