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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 10/10/2023Voluntary Recall of Certain
Over-the-Counter Drugs and Medical DevicesDrugs, Medical Devices, Temperature
Abuse10/03/2023KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of
Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a Precautionary Measure
Due to a Single Foreign Tablet Found During the Line Clearance After the Batch
was PackagedDrugs, Potential Packaging Issue10/02/2023Biomic Sciences Issues
Voluntary Nationwide Recall of ION* Sinus Support, ION* Sinus, and Restore Sinus
Spray Products Due to Microbial ContaminationDrugs, Microbial
Contamination10/02/2023Hospira, Inc. Issues a Voluntary Nationwide Recall for
4.2% Sodium Bicarbonate Injection, USP and 1% and 2% Lidocaine HCl Injection,
USP Due to the Potential for Presence of Glass Particulate MatterDrugs,
Potential Foreign Material09/29/20232023 Safety CommunicationsMedical Devices,
Radiation-Emitting Products09/29/2023Risk of Invasive Disease in Preterm Infants
Given Probiotics Formulated to Contain Live Bacteria or Yeast Biologics,
Drugs09/29/2023Update: Recommendations for Certain O&M Halyard Surgical N95
Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety
CommunicationMedical Devices09/28/2023SCYNEXIS Issues a Voluntary Nationwide
Recall of BREXAFEMME® (ibrexafungerp tablets) Due to Potential for Cross
Contamination with a Non-Antibacterial ßlactam Drug SubstanceDrugs, Potential
Foreign Material09/22/2023Hamilton Medical Inc. Recalls HAMILTON-C1, C2, C3, T1
Ventilators for Software Issues that May Cause Ventilators to Stop Without
NoticeMedical Devices09/22/2023Universal Meditech Inc. Expands Nationwide Recall
to All Products Manufactured between March 2021 and November 2022Defect, Medical
Devices

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