Image Avoid using imported medicines, especially for children. Medications from other countries might not have been evaluated for safety and effectiveness. These products may be addictive or contain other dangerous ingredients. Español Although most colds in children don’t cause serious complications, they can cause stress and worry in parents and caregivers. It’s understandable that you…
Smiths Medical Issues Urgent Medical Device Correction Letter Notifying Customers of Potential Issues with CADD™ Infusion System Infusion Sets for Use with CADD Pumps
Summary Company Announcement Date: December 12, 2022 FDA Publish Date: January 05, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms. Company Name: Smith’s Medical Brand Name: Brand Name(s) Smith’s Medical Product Description: Product Description CADD Infusion System Infusion Sets…
ACTUALIZACIÓN: Se retiran del mercado ciertos ventiladores, máquinas BiPAP y máquinas CPAP de Philips Respironics debido a posibles riesgos para la salud: Comunicado de seguridad de la FDA
English ACTUALIZACIÓN – 22 de diciembre de 2022: La FDA emitió un comunicado de seguridad para proporcionar información adicional a pacientes, cuidadores y proveedores de atención médica sobre dos problemas recientes en ciertos ventiladores Trilogy 100 y Trilogy 200 de Philips Respironics (Philips) reacondicionados. Estos ventiladores Philips Trilogy 100 y Trilogy 2000 fueron retirados del…
Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, Due To The Presence of Visible Glass Particulates
Summary Company Announcement Date: December 22, 2022 FDA Publish Date: December 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Visible Glass Particulates Company Name: Hospira, Inc. Brand Name: Brand Name(s) Hospira, Inc. Product Description: Product Description Vancomycin Injection Company Announcement December 22, 2022 – NEW YORK, NY., Hospira, Inc., a…
FDA D.I.S.C.O. Burst Edition: FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)
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 November 18, 2022, the FDA approved a new Monday-Wednesday-Friday…
Accord Healthcare Inc. Issues Nationwide Voluntary Recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot # R2200232 Due to Product Mix-Up
Summary Company Announcement Date: December 23, 2022 FDA Publish Date: December 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeling Company Name: Accord Healthcare, Inc Brand Name: Brand Name(s) Product Description: Product Description Daptomycin for Injection Company Announcement – December 22, 2022 – Durham, North Carolina, Accord Healthcare, Inc. is voluntarily recalling…
GFA Production (Xiamen) Co., Ltd. Issues Voluntary Nationwide Recall of Easy Care First Aid® Burn Cream and First Aid Kits Due to Microbial Contamination
Summary Company Announcement Date: December 23, 2022 FDA Publish Date: December 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is contaminated with Bacillus licheniformis and Bacillus sonorensis. Company Name: GFA Production Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description After Burn® Cream and First Aid Kits containing After…
Whele LLC Recalls Mighty Bliss Electric Heating Pads Due to Injury Risks Including Electric Shocks, Skin Burns, and Rashes
The recall described in this notice is for the same issue that was announced in Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication | FDA on October 25, 2022. The FDA has identified this as a Class I recall, the most serious type of recall. Use…
Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris: FDA Safety Communication
Date Issued: December 22, 2022 The U.S. Food and Drug Administration (FDA) is providing additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. These Philips Trilogy 100 and Trilogy 200 ventilators were recalled in June 2021 for issues with…
Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Four Lots of Quinapril Tablets Due to Potential Presence of N-Nitroso-Quinapril Impurity
Summary Company Announcement Date: December 21, 2022 FDA Publish Date: December 21, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of nitrosamine impurity, N-Nitroso-Quinapril Company Name: Lupin Pharmaceuticals Inc. Brand Name: Brand Name(s) Product Description: Product Description Quinapril 20 and 40 mg tablets Company Announcement Baltimore, Maryland, December 21, 2022: Lupin Pharmaceuticals…