Summary Company Announcement Date: July 06, 2023 FDA Publish Date: July 07, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Failure to deliver the recommended dose Company Name: Cipla Brand Name: Brand Name(s) Product Description: Product Description Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) Company Announcement FOR IMMEDIATE RELEASE – Mumbai,…
UPDATE: NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers
June 28, 2023 The U.S. Food and Drug Administration (FDA) is providing an update to information and recommendations for the NuVasive Specialized Orthopedics’ (NuVasive) Precice Intra-medullary Limb Lengthening (IMLL) system, which includes Precice Short. In March 2023, NuVasive received FDA 510(k) clearance for the expanded use of the Precice IMLL system (including Precice Short) for…
Teleflex, and Arrow International, Recall ARROW Endurance Extended Dwell Peripheral Catheter System for Risk of Catheter Separation and Leakage
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: ARROW Endurance Extended Dwell Peripheral Catheter System Product Codes: See Recall Database Entry Devices Recalled in the U.S.: 262,016 Dates Distributed: October 26, 2018 to…
The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg Due to Label Mix-up
Summary Company Announcement Date: June 13, 2023 FDA Publish Date: June 14, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Packaging may contain incorrect product due to labeling mix-up Company Name: The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories Brand Name: Brand Name(s) Major Pharmaceuticals Product Description: Product Description Dronabinol…
BearCare, Inc. Recalls Rechargeable Walnut Wearable Smart Thermometers for Risks of Serious Injury, including Burns 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 Product Name: Walnut Wearable Smart Thermometer Product Model Number: WT20 Product Lot Number: 20221115W002 Devices Recalled in the U.S.: 979 Dates Distributed: December 1, 2022 – April…
Oxygenator Devices Used for Extracorporeal Circulation – Letter to Health Care Providers
June 9, 2023 The U.S. Food and Drug Administration (FDA) is providing information to health care providers and facilities on the use of oxygenators in extracorporeal circulation. On May 18, 2023, Getinge/Maquet issued an Urgent Medical Device Removal notice to inform users to not use all Quadrox Oxygenators and certain Getinge/Maquet Venous Hardshell Cardiotomy…
Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support
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: Impella 5.5 with SmartAssist Product Code: 0550-0008 Product Serial Numbers: See Recall Database Entry Distribution Dates: September 28, 2021 to March 6, 2023 Devices Recalled…
Non-sterile, Single-use Pneumatic Tourniquet Cuffs Conservation Strategies – Letter to Health Care Providers
June 5, 2023 The U.S. Food and Drug Administration (FDA) is aware of health care facilities and providers experiencing localized supply constraints of non-sterile, single-use pneumatic tourniquet cuffs in the United States. These devices are mainly used in elective limb surgeries and in emergency and trauma settings. During interruption in the supply of these devices,…
ACTUALIZACIÓN: Uso del dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicación de seguridad de la FDA
English Fecha de publicación: 10 de mayo de 2023 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está proporcionando otra actualización sobre el sistema de dispositivos Renuvion/J-Plasma de Apyx Medical con respecto al uso del dispositivo para ciertos procedimientos estéticos de la piel y una autorización adicional…
FDA Updating Warnings to Improve Safe Use of Prescription Stimulants Used to Treat ADHD and Other Conditions.
[Posted 05/26/2023] AUDIENCE: Patient, Health Professional, Pharmacy, Psychiatry, Pediatrics ISSUE: The FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines. The current prescribing information for some prescription stimulants does not provide up to date warnings about the harms of…