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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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   therapies.
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Product Type Biologics Drugs Medical Devices
Year 202220212020201920182017
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DateSafety AlertProduct Type 04/12/2022Mylan Pharmaceuticals Inc., a Viatris
Company, Conducting Voluntary Nationwide Recall of One Batch of Insulin Glargine
(Insulin glargine-yfgn) Injection, 100 units/mL (U-100), Due to the Potential
for a Missing Label in the Batch Drugs, Mislabeling04/11/2022Intended Use of
Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health Care
ProvidersMedical Devices04/05/20222022 Safety CommunicationsMedical Devices,
Radiation-Emitting Products04/05/2022Use Duodenoscopes with Innovative Designs
to Enhance Safety: FDA Safety CommunicationMedical
Devices04/05/2022Recommendations About the Use of Dental Amalgam in Certain
High-Risk Populations: FDA Safety CommunicationMedical Devices04/05/2022The FDA
is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance
Safety: FDA Safety Communication04/04/2022 Infections Associated with
Reprocessed Urological Endoscopes - Letter to Health Care ProvidersMedical
Devices04/04/2022UPDATE: Change in Reprocessing Methods with Certain Karl Storz
Urological Endoscopes – Letter to Health Care ProvidersMedical
Devices04/01/2022Best Brand Consumers Products, Inc. Issues Voluntary Recall of
Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% Due to Presence of Methanol and
the Mandalorian Hand Sanitizer Ethyl Alcohol 68% Due to the Presence of
BenzeneDrugs, Unapproved Ingredient04/01/2022F&S Medical Supply, DBA Pink Toyz
Issues Voluntary Nationwide Recall of Pink Pussycat Capsules Due to the Presence
of Undeclared SildenafilDrugs, Unapproved Drug

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