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FDA Drug Safety Information for September 23, 2024

Sep 232024

Date Brand Name(s) Description Type Reason Company 9/23/2024 Gilead Veklury (remdesivir) for Injection Drugs Due to Presence of Glass Particle Gilead Sciences, Inc.

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 Novel Drug Approvals – August 2024

Sep 012024

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Lazcluze lazertinib 8/19/2024 To treat non-small cell lung cancer

FDA Drug Safety Information for August 12, 2024

Aug 122024

Date Brand Name(s) Description Type Reason Company 8/12/2024 Tandem T:Connect Mobile App for iOS Devices Medical Devices Rapid Depletion of a User’s t:slim X2 Insulin

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 8, 2024

Aug 082024

Date Brand Name(s) Description Type Reason Company 8/8/2024 B Braun 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers Drugs Potential for particulate

Updated Drug Shortage Information for August 8, 2024

Aug 082024

New Shortages August 08, 2024 Bromocriptine Mesylate Tablet (Discontinuation)

Updated Drug Shortage Information for August 7, 2024

Aug 072024

New shortages August 07, 2024 Memantine Hydrochloride Capsule, Extended Release (Discontinuation)

Updated Drug Shortage Information for August 6, 2024

Aug 062024

Shortage Updates August 06, 2024 Carboplatin Injection (Currently in Shortage) Semaglutide Injection (Currently in Shortage)

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