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MEDWATCH: THE FDA SAFETY INFORMATION AND ADVERSE EVENT REPORTING PROGRAM

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MedWatch, the FDA’s medical product safety reporting program for health
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MedWatch receives reports from the public and when appropriate, publishes safety
alerts for FDA-regulated products such as:

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 * Biologics such as blood components, blood/plasma derivatives and gene
   therapies.
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Product Type Biologics Drugs Medical Devices
Year 2023202220212020201920182017
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DateSafety AlertProduct Type 05/05/2023Recall Notice - SD Biosensor, Inc.
Requests Discontinuation of Use and Disposal of Specific Pilot™ COVID-19 At-Home
Tests in the United States Due to Microbial Contamination in the Liquid Buffer
SolutionDefect, Medical Devices05/04/2023 Do Not Use Ultraviolet (UV) Wands That
Give Off Unsafe Levels of Radiation: FDA Safety CommunicationRadiation-Emitting
Products05/04/20232023 Safety CommunicationsMedical Devices, Radiation-Emitting
Products05/04/2023Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests:
FDA Safety Communication05/04/2023Family Dollar is Initiating a Voluntary Recall
of Certain Over-the-Counter Drug Products Because the Products Have Been Stored
Outside of Labeled Temperature RequirementsDrugs, Over-the-Counter Drugs,
Potential Lack of Sterility05/04/2023Risk of Exposure to Unsafe Levels of
Radiation with Safe-T-Lite UV WAND: FDA Safety CommunicationMedical
Devices05/04/2023UPDATE - Akorn Issues Voluntary Nationwide Recall of Various
Human and Animal Drug Products Within Expiry Due to Company ShutdownDefect,
Drugs05/02/2023Avanos Medical Inc Recalls Certain BALLARD ACCESS Closed Suction
Systems for Neonates/Pediatrics for Risk of Inadequate Ventilation, Other
Injuries from Cracked ManifoldsMedical Devices04/28/2023Teva Initiates Voluntary
Nationwide Recall of Specific Lots of FENTANYL Buccal Tablets CII Due to a
Labeling ErrorDrugs, Mislabeling04/27/20232023 Letters to Health Care
ProvidersMedical Devices, Radiation-Emitting Products

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