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MedWatch: The FDA Safety Information and Adverse Event Reporting Program

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

 

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2019 Safety Alerts for Human Medical Products

June 2019
May 2019
April 2019

 

March 2019
  • DG/Health NATURALS Baby Cough Syrup + Mucus by Kingston Pharma: Recall - Possible Health Risk intended for Consumer, Pediatrics, Pharmacy. [03/22/2019] 
  • BLUEFUSION Capsules by Ata Int: Recall - Due to Presence of Undeclared Sildenafil, Tadalafil, Desmethyl Carbodenafil, Dithiodesmethyl Carbodenafil, Scutellarin and Daidzein intended for Consumer, Pharmacy, Urology. [03/22/2019]
  • Levoleucovorin Injection by Mylan Institutional: Recall - Due to the Presence of Particulate Matter intended for Health Professional, Risk Manager, Pharmacy. [03/19/2019]
  • Transseptal Needle by Cook Medical: Class I Recall - Due to Risk of Detached Plastic Fragments intended for Health Professional, Risk Manager. [03/18/2019]
  • 8.4% Sodium Bicarbonate Injection by Hospira: Recall - Due to the Presence of Particulate Matter intended for Health Professional, Risk Manager, Pharmacy. [03/18/2019]
  • Losartan Potassium Tablets by Legacy Pharmaceutical Packaging (by Camber Pharmaceuticals and by Torrent Pharmaceuticals): Recall - Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid Impurity Found in The Active Pharmaceutical Ingredient intended for Patient, Health Professional, Pharmacy. [03/18/2019]
  • Levoleucovorin Injection by Mylan Institutional: Recall - Due to the Presence of Particulate Matter intended for Health Professional, Risk Manager, Pharmacy. [03/19/2019]
  • Transseptal Needle by Cook Medical: Class I Recall - Due to Risk of Detached Plastic Fragments intended for Health Professional, Risk Manager. [03/18/2019]
  • 8.4% Sodium Bicarbonate Injection by Hospira: Recall - Due to the Presence of Particulate Matter intended for Health Professional, Risk Manager, Pharmacy. [03/18/2019]
  • Losartan Potassium Tablets by Legacy Pharmaceutical Packaging (by Camber Pharmaceuticals and by Torrent Pharmaceuticals): Recall - Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid Impurity Found in The Active Pharmaceutical Ingredient intended for Patient, Health Professional, Pharmacy. [03/18/2019]
  • Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents: Letter to Health Care Providers - Potential for Increased Long-term Mortality After Use intended for Cardiology, Risk Manager, Health Professional. [03/15/2019]
  • Pilocarpine 0.1% Ophthalmic Solution by Stokes Healthcare: Recall - Due to a High Level of Preservative intended for Consumer, Eye Care, Health Professional. [03/14/2019]
  • Valsartan Tablets USP, 160 mg by American Health Packaging: Recall - Due to Detection of N-Nitrosodiethylamine (NDEA) Impurity. [03/08/2019]
  • LifeVest 4000 Wearable Cardioverter Defibrillator by Zoll: Safety Communication - Software Update intended for: Cardiology, Patient, Health Professional. [03/06/2019] 
February 2019
  • Robotically-Assisted Surgical Devices: Safety Communication - Caution When Using in Women's Health including Mastectomy and Other Cancer-Related Surgeries intended for: Patient, Oncology, Surgery, Health Professional. [02/28/2019]
  • LIFEPAK15 by Physio-Control: Class I Recall - Due to Risk of Device "Lockup" (Freezing). [02/27/2019]
  • Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients intended for: Patient, Health Professional, Pharmacy, Rheumatology. [02/25/2019]
  • FDA Warns Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or Screen for Breast Cancer intended for: Oncology, Radiology, Health Professional. [02/25/2019] ChemoLock Vial Spike by ICU Medical: Class I Recall - Due to Risk of Detached Plastic Particles. [02/22/2019]
  • Uloric (febuxostat): Boxed Warning Added - Due to Increased Risk of Death with Gout Medicine intended for: Health Professional, Patient, Pharmacy. [02/21/2019]
  • Dual Chamber Implantable Pulse Generators by Medtronic: Recall - Due to Possible Circuit Error. [02/15/2019]
  • Breast Implants: Letter to Health Care Providers - Due to Associated-Anaplastic Large Cell Lymphoma. [02/07/2019]
  • Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL by Dr. Reddy's Laboratories: Recall - Due to Mislabeling. [02/05/2019]
  • Impella RP System by Abiomed: Letter to Health Care Providers - Increased Rate of Mortality intended for: Cardiology, Surgery, Transplantation. [02/04/2019]
  • Sterile Saline and Sterile Water for Inhalation by Medex Cardio-Pulmonary, Doing Business as Smiths Medical: Class I Recall - Due to Potential Exposure to Infectious Agents as a Result of Leaking Containers. [02/04/2019] FDA Warns Compounders Not to Use Glutathione from Letco Medical to Compound Sterile Drugs Intended for: Pharmacy, Risk Manager. [02/01/2019]
  • LIFEPAK 15 Monitor/Defibrillator by Stryker: Recall - Due to Lock Up (blank monitor display with LED lights on) after a Defibrillation Shock is Delivered. [02/01/2019]
  • CoaguChek XS PT Test Strips by Roche Diagnostics: Recall - Due to Inaccurate Test Results. [02/01/2019]
  • Vial2Bag Fluid Transfer Systems by West Pharmaceutical Services: Recall - Due to Potential Malfunctions. [02/01/2019]
January 2019
  • Infants’ Ibuprofen Concentrated Oral Suspension by Tris Pharma: Recall - Due to Potential Higher Concentrations of Ibuprofen. [01/30/2019]
  • Silver Bullet 10x by Nature’s Rx: Recall - Due Undeclared PDF-5 Inhibitors in the Product. [01/29/2019]
  • VentStar and ID Breathing Circuits and Anesthesia Sets by Draeger Medical: Class I Recall - Due to a Risk of the Devices Being Incorrectly Assembled. [01/25/2019]
  • Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP by Torrent Pharmaceuticals: Recall Due to the Detection of N-nitrosodiethylamine (NDEA). [01/23/2019]
  • Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality When Used for Treatment of Peripheral Arterial Disease - Letter to Health Care Providers. [01/17/2019]
  • Synergy Cranial Software and Stealth Station S7 Cranial Software by Medtronic: Recall - Due to Inaccuracies Displayed During Surgical Procedures. [01/08/2019]


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.