Summary Company Announcement Date: June 22, 2022 FDA Publish Date: June 22, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries Company Name: BD Brand Name: Brand Name(s) Product Description: Product…
Medtronic Recalls HeartWare HVAD System Batteries Due to 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 Product Names: Medtronic HVAD Batteries Product Codes: See Recall Database Entry Model Number: 1650DE Manufacturing Dates: April 13, 2021 to April 19, 2021 Distribution Dates: April 20,…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line advanced or metastatic esophageal squamous cell carcinoma, and Kymriah (tisagenlecleucel) for relapsed or refractory follicular lymphoma
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 another quick update on two recent FDA cancer drug approvals. On May 27, 2022, the FDA approved the following for…
Baxter Healthcare Corporation Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients During Home 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 Product Name: Volara system with in-line ventilator adaptor (OPTIMUS Handset 2) or Volara patient circuit kit (OPTIMUS OLE AC Patient Circuit Kit) Product Model Numbers: PVLIHCBA, M08594,…
Vi-Jon, LLC Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination
Summary Company Announcement Date: June 22, 2022 FDA Publish Date: June 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination with Gluconacetobacter liquefaciens Company Name: Vi-Jon, LLC Brand Name: Brand Name(s) CVS Health Product Description: Product Description Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor Company Announcement June 21, 2022 –…
FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication (UNPUBLISHED)
Date Issued: May 7, 2019 Audience: Patients with a Medtronic pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) Caregivers of patients with a Medtronic pacemaker or CRT-P Cardiologists, electrophysiologists, cardiac surgeons, and primary care physicians treating patients with heart failure or heart rhythm problems using a Medtronic pacemaker or CRT-P Medical Specialties: Cardiac Electrophysiology, Cardiology, Cardiothoracic…
FDA D.I.S.C.O. Burst Edition: FDA approval of Tibsovo (ivosidenib) in combination with azacitidine for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy
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 another quick update on a recent FDA cancer drug approval. On May 25, 2022, the FDA approved ivosidenib (brand name…
Latin Foods Market Issues Voluntary Nationwide Recall of Artri King Reforzado Con Ortiga Y Omega 3 Due to the Presence of Undeclared Diclofenac and Dexamethasone
Summary Company Announcement Date: June 10, 2022 FDA Publish Date: June 14, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Diclofenac and Dexamethasone Company Name: Latin Foods Market Brand Name: Brand Name(s) Product Description: Product Description Artri King Reforzado con Ortiga y Omega 3 Company Announcement Latin Foods Market is voluntarily recalling…
Walmart Inc. Issues Voluntary Nationwide Recall of Various Artri Ajo King Joint Supplements Due to Potential Hidden Drug Ingredients
Summary Company Announcement Date: May 28, 2022 FDA Publish Date: May 28, 2022 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Contains diclofenac Company Name: Walmart Inc. Brand Name: Brand Name(s) Artri Ajo King Product Description: Product Description Joint supplements Company Announcement Walmart Inc. is voluntarily recalling all lots of Artri Ajo King…
Infant Formula Supply
Image In the coming weeks and months, you should see more infant formula on store shelves as the U.S. Food and Drug Administration helps to increase supply to address production and distribution issues. Some of the products will be new to the U.S. market, and therefore new to you. It is important to talk with…