FDA Drug Safety Information for October 16, 2024

Oct 162024
 

Date Brand Name(s) Description Type Reason Company  10/16/2024 STASKA Pharmaceuticals Ascorbic Acid Solution for Injection Drugs Device & Drug Safety – Presence of glass particulates

FDA Drug Safety Information for October 7, 2024

Oct 072024
 

Date Brand Name(s) Description Type Reason Company  10/7/2024 Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators Medical Devices The

FDA Drug Safety Information for September 18, 2024

Sep 182024
 

Date Brand Name(s) Description Type Reason Company  9/18/2024 BionPharma Atovaquone Oral Suspension, 750 mg/mL Drugs Product found to be contaminated with Cohnella bacteria Bionpharma Inc.

FDA Drug Safety Information for September 4, 2024

Sep 042024
 

Date Brand Name(s) Description Type Reason Company  9/4/2024 Bivona Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™

FDA Drug Safety Information for August 9, 2024

Aug 092024
 

Date Brand Name(s) Description Type Reason Company  8/9/2024 Breas Vivo 45 LS (US Version) Ventilator Medical Devices Potential for short term elevated levels of formaldehyde

FDA Drug Safety Information for August 6, 2024

Aug 062024
 

Date Brand Name(s) Description Type Reason Company  8/6/2024 Baxter Heparin Sodium in 0.9% Sodium Chloride Injection Drugs Elevated endotoxin levels Baxter International Inc

FDA Drug Safety Information for July 31, 2024

Jul 312024
 

Date Brand Name(s) Description Type Reason Company  7/31/2024 Abbott FreeStyle Libre® 3 sensors Medical Devices Sensors may provide incorrect high glucose readings Abbott

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