[Posted 03/03/2023] AUDIENCE: Allergy and Immunology, Pediatrics, Health Professional, Patient ISSUE: In 2022, during safety monitoring of FDA Adverse Event Reporting System (FAERS) data, FDA became aware of increased postmarketing adverse event reporting of false negative skin test results with certain lots of ALK-Abello’s Allergenic Extract – Peanut (Arachis hypogaea) – For Diagnostic Use Only. Some of these reports of…
Apotex Corp. Issues Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% Due to Cracks that Have Developed in Some of the Units Caps of the Bottles
Summary Company Announcement Date: March 01, 2023 FDA Publish Date: March 02, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential lack of sterility. Company Name: Apotex Corp. Brand Name: Brand Name(s) Product Description: Product Description Brimonidine Tartrate Ophthalmic Solution, 0.15% Company Announcement FOR IMMEDIATE RELEASE – March 01, 2023 – Weston, Florida,…
Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced – Letter to Health Care Providers
March 1, 2023 The U.S. Food and Drug Administration (FDA) is alerting health care facilities and providers about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohelp system. The disposable part is the HLS Set Advanced that contains the oxygenator, heat exchanger, and integrated centrifugal pump. On February 13, 2023, Getinge/Maquet issued…
Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration- Letter to Health Care Providers
February 27, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which feature leaflets externally mounted to the valve frame. Information from published literature…
ACTUALIZACIÓN: Uso del Dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicado de seguridad de la FDA
English ACTUALIZACIÓN – 27 de febrero de 2023 – El 23 de febrero de 2023, la Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) autorizó el Renuvion APR Handpiece para la administración de energía de radiofrecuencia y/o plasma de helio donde se necesita la coagulación/contracción del tejido blando. El…
Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial Contamination
Summary Company Announcement Date: February 23, 2023 FDA Publish Date: February 24, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to possible microbial contamination Company Name: Global Pharma Healthcare Brand Name: Brand Name(s) Delsam Pharma’s Product Description: Product Description Artificial Eye Ointment Company Announcement FOR IMMEDIATE RELEASE – February 23, 2023, Global…
Evaluation of Airborne Chemicals from Neonatal Incubators – Letter to Health Care Providers
February 23, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers and facilities about the potential for exposure to airborne chemicals that may be released from neonatal incubators. The FDA is evaluating published literature that reports elevated levels of formaldehyde, cyclohexanone, and other volatile chemicals (such as human-made chemicals used and…
nanoMaterials Discovery Corporation Issues Voluntary Nationwide Recall of its Alcohol Antiseptic 80% Alcohol Solution
Summary Company Announcement Date: February 14, 2023 FDA Publish Date: February 21, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to presence of methanol Company Name: nanoMaterials Discovery Corporation Brand Name: Brand Name(s) nanoMaterials Discovery Corporation Product Description: Product Description Hand Sanitizer Company Announcement FOR IMMEDIATE RELEASE – February 14, 2023 –…
Philips Respironics Recalls Certain Reworked Philips Respironics Trilogy 100/200 and Garbin Ventilators Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris
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: Philips Respironics Trilogy 100, Trilogy 200, and Garbin Plus ventilators Product Models and Serial Numbers: See recall database entries Distribution Dates: March 1, 2022, to…
GE HealthCare Recalls Nuclear Medicine 600/800 Series Systems for Risk of Detector Fall That May Injure Patients
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: Nuclear Medicine 600/800 Series systems Product Models: Brivo 615 Discovery NM 630 Optima 640 Discovery NM/CT: 670 DR, 670 ES, 670 Pro, 670 CZT NM:…