Date Issued: August 20, 2021 The U.S. Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In addition, the FDA is aware of allegations…
Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination – Letter to Health Care Providers
August 18, 2021 The U.S. Food and Drug Administration (FDA) is informing health care providers, health care facility risk managers, and procurement staff to immediately stop using and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc., due to risk of bacterial contamination with Burkholderia cepacia complex (Bcc). Products manufactured by Eco-Med are…
Pfizer Expands Voluntary Nationwide Recall to include Four Additional Lots of CHANTIX® (varenicline) Tablets Due to N- Nitroso Varenicline Content
Summary Company Announcement Date: August 16, 2021 FDA Publish Date: August 16, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description N-Nitroso Varenicline content above acceptable daily intake level Company Name: Pfizer Brand Name: Brand Name(s) Product Description: Product Description Smoking cessation treatment Company Announcement Pfizer is voluntarily recalling an additional four lots of…
Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Transition to Safety Mode
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: INGENIO Family of Pacemakers and CRT-Ps (includes models ADVANTIO DR EL, INGENIO DR EL and VITALIO DR EL) Product Codes: LWP Model Numbers: J174, J177,…
Medtronic Stops Distribution and Sale of HeartWare HVAD System Due to Risk of Neurological Adverse Events, Mortality, and Potential Failure to Restart
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. The recall described in this notice is the same one that was announced in the Stop New Implants of the Medtronic HVAD System – Letter to Health Care Providers…
5 Things You Need to Know about the COVID-19 Vaccine for Adolescents 12 through 17
[embedded content] From babies to teenagers, people need vaccines throughout childhood to provide them with immunity from potentially dangerous infectious diseases. If individuals choose not to vaccinate themselves or their children, some diseases that are now rare or nonexistent in the United States may resurface. The FDA has authorized the Pfizer-BioNTech COVID-19 Vaccine for emergency…
Baxter Healthcare Recalls Dose IQ Software Version 9.0.x, Used with Spectrum IQ Infusion Pumps, for Software Defect That May Improperly Configure Drug and Fluid Delivery
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 Dose IQ Safety Software (used with Spectrum IQ Infusion System) Product Code: 35723V091 Software Version: All drug libraries initially created with version 9.0.x Distribution Dates: February 1,…
Jongu 4308 Issues Voluntary Nationwide Recall of Hydro Pineapple Burn Due to the Presence of Undeclared Sibutramine.
Summary Company Announcement Date: August 11, 2021 FDA Publish Date: August 11, 2021 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description undeclared sibutramine Company Name: Ebay Seller-John Nguyen Brand Name: Brand Name(s) Max Health Product Description: Product Description Hydro Pineapple Burn Company Announcement Houston, Texas, eBay Seller ID: jongu 4308 is voluntarily recalling…
Desayunos saludables para niños: Todo es cuestión de balance
Image English Un desayuno saludable es vital para los niños. Si no desayunan, sus niños pasaran el día tratando de recuperar esos nutrientes, dice la Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés). Los cuerpos en crecimiento y cerebros en desarrollo necesitan comidas regulares y saludables. Según la Academia de Nutrición y…
FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for high-risk early-stage triple-negative breast 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 another recent FDA cancer drug approval. On July 26, 2021, the FDA approved pembrolizumab (brand name…