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 3. MedWatch: The FDA Safety Information and Adverse Event Reporting Program

 1. Safety


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
professionals, patients and consumers.

   Report a Problem
   Safety Information
   Stay Informed

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.
 * Medical devices such as hearing aids breast pumps, and pacemakers.
 * Combination products such as pre-filled drug syringe, metered-dose inhalers
   and nasal spray.
 * Special nutritional products such as dietary supplements, medical foods and
   infant formulas.
 * Cosmetics such as moisturizers, makeup, shampoos, hair dyes and tattoos.
 * Food such as beverages and ingredients added to foods.

Other products that the FDA regulates such as tobacco products, vaccines and
animal/livestock medicine and feed utilize different reporting pathways and it
is recommended that reports concerning these products be submitted directly to
the appropriate portals.




Search Showing 1 to 10 of 675 entries


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Product Type Biologics Drugs Medical Devices
Year 2020201920182017
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DateSafety AlertProduct Type 10/07/2020Recommendations on Providing Clear
Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a
Health Care Setting for SARS-CoV-2 Testing - Letter to Health Care
ProvidersMedical Devices10/05/2020Marksans Pharma Limited Issues Expansion of
Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets,
USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)Drugs,
Impurity10/02/2020Ashtel Studios Issues Voluntary Recall of Licensed Hand
Sanitizers Packaged in 0.84 Fluid Ounce Pouches Due to Misbranding Because They
Resemble Food and Drink Container PouchesDrugs, Potential Packaging
Issue10/02/2020Becton Dickinson CareFusion 303, Inc. Recalls Alaris™ System Pump
Module and Pump Module Door Assembly Replacement Kits Due to the Potential for
Stuck or Unresponsive Keys09/30/2020DMM VISSION, S.A. DE C.V. Issues Voluntary
Nationwide Recall of Cleaner Hand Sanitizer 500 mL and 1200 mL Bottles Due to
the Possible Presence of Undeclared Methanol (Wood Alcohol)Drugs,
Impurity09/30/2020Potential Risk of Infection during Cardiac Surgery When Using
the CardioQuip Modular Cooler-Heater Device – Letter to Health Care
ProvidersMedical Devices09/25/20202020 Safety CommunicationsMedical
Devices09/25/2020Mammography Problems at Allison Breast Center at Monument
Radiology in Richmond, Virginia: FDA Safety CommunicationMedical Devices,
Radiation-Emitting Products09/24/2020Recommendations About the Use of Dental
Amalgam in Certain High-Risk Populations: FDA Safety CommunicationMedical
Devices09/24/2020Benadryl (diphenhydramine): Drug Safety Communication - Serious
Problems with High Doses of the Allergy MedicineDrugs, Over-the-Counter Drugs

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 * MedWatch: The FDA Safety Information and Adverse Event Reporting Program
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MEDWATCH - THE FDA SAFETY INFORMATION AND ADVERSE EVENT REPORTING PROGRAM

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serious problems with human medical products.

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