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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:

 * Prescription and over-the-counter medicines
 * Biologics such as blood components, blood/plasma derivatives and gene
   therapies.
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Product Type Biologics Drugs Medical Devices
Year 202220212020201920182017
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DateSafety AlertProduct Type 10/25/20222022 Safety CommunicationsMedical
Devices, Radiation-Emitting Products10/25/2022Aurobindo Pharma USA, Inc.
Initiates Voluntary Nationwide Recall of Two (2) Lots of Quinapril and
Hydrochlorothiazide Tablets USP 20mg/12.5mg, Due to the Detection of N-Nitroso
Quinapril ImpurityDrugs, Impurity10/25/2022Do Not Use Certain Mighty Bliss
Electric Heating Pads Due to Risk of Injury: FDA Safety CommunicationMedical
Devices10/25/2022Mylan Institutional LLC, a Viatris Company, Issues a Voluntary
Recall of One Lot of Octreotide Acetate Injection, 500 mcg/mL, Due to Glass
Particulates in a SyringeDrugs, Potential Foreign Material10/24/2022Baxter
Issues Urgent Medical Device Correction Regarding Potential Radio Frequency
Interference With Other Devices Near Beds Installed With WatchCare SystemMedical
Devices, Unapproved Use10/24/2022Whele LLC Announces National Voluntary Recall
of Mighty Bliss Electric Heating Pad Due to Product Safety ConcernsDefect,
Medical Devices10/19/2022 Certain Philips Respironics Masks for BiPAP, CPAP
Machines Recalled Due to Safety Issue with Magnets That May Affect Certain
Medical Devices: FDA Safety CommunicationMedical Devices10/19/20222022 Medical
Device RecallsMedical Devices, Radiation-Emitting Products10/19/2022FAQs on
Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine RecallsMedical
Devices10/19/2022Philips Respironics Recalls Certain Masks for BiPAP, CPAP
Machines Due to Safety Issue with Magnets That May Affect Certain Medical
Devices

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