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Alerts
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2017
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December 2017
- inezolid Injection by Auromedics Pharma: Voluntary Recall
- Physio-Control Inc. Recalls Defibrillation Electrodes Due to Incorrect Placement Instructions for Infants Depicted on Artwork
- Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings
- AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Pantoprazole Sodium for Injection 40 Mg Per Vial
- Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label
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November 2017
- The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication
- Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination
- FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel
- FDA Statement: Impact of IV Fluid Shortages Following Hurricane Destruction
- Baxter Issues A Voluntary Nationwide Recall For One Lot of Nexterone Injection Due To Presence Of Particulate Matter
- Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death
- Midazolam Injection, USP, 2 mg/2 mL by Fresenius Kabi: Recall
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October 2017
- St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D)
- Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall
- Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination
- Advice for Providers Treating Patients in or Recently Returned from Hurricane-Affected Areas, Including Puerto Rico and US Virgin Islands
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September 2017
- Hurricanes Irma and Maria in the Caribbean Alert - Level 2, Practice Enhanced Precautions
- Class 2 Device Recall Baxter Amia Automated Peritoneal Dialysis Set with Cassette
- Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury
- Guidance to All Providers Regarding Provision of Services During Hurricane Irma: This Guidance Applies for Both Fee-For-Service and Managed Care Providers
- Rifampin/Penicillin-Resistant Strain of RB51 Brucella Contracted from Consumption of Raw Milk
- Medtronic Announces Voluntary Recall of Diabetes Infusion Sets
- Activase (alteplase) 100mg by Genentech: Recall - Lack of Sterility Assurance
- Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing
- Hurricane Harvey—Clinical Guidance for Carbon Monoxide (CO) Poisoning
- Hospira Issues Voluntary Worldwide Recall For Lots of Hydromorphone HCl Injection
- Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert - Lack of Sterility Assurance and Other Quality Issues
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August 2017
- Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold
- Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira: Recall - Presence of Particulate Matter
- Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication - Firmware Update to Address Cybersecurity Vulnerabilities
- Texas Board of Nursing (BON) to Implement Disaster Licensing Procedure
- ESRD Network of Texas Disaster Updates
- Harvey: A Life Threatening Hurricane
- Bella Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance
- Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals: Recall - Misprinted Dosing Droppers
- Pravastatin Sodium Tablets by International Laboratories: Recall - Mislabeling
- Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory - Not to Use
- Increase in Reported cases of Cyclospora cayetanensis Infection, United States, Summer 2017
- Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination
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July 2017
- 0.9% Sodium Chloride Injection by ICU Medical: Recall
- Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling
- Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance
- Novo Nordisk Recalls Cartridge Holders In Certain Novopen Echo® Insulin Delivery Devices Due to Potential Health Risks
- June 2017
- May 2017
- April 2017
- March 2017
- February 2017
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January 2017
- FDA MedWatch: Vancomycin Hydrochlorida for Injection, USP by Hospira–Recall
- CDC Health Advisory: Investigation of Seoul Virus Outbreak Associated with Home-based, Rat breeding Facilities in WI and IL
- FDA Class 2 Recall: Fresenius 2008 Dialysis Machines due to UF Rate Errors
- RECALL: Tego Connector No. D1000, NM1000
- Lifepak 1000 Defibrillators by Physio-Control: Remove and Reinstall Battery
- FDA Medical Device Recall: Nurse Assist Normal Saline Flush IV Syringes
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December 2017
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2016
- December 2016
- November 2016
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October 2016
- Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue
- FDA MedWatch: Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected
- Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating
- September 2016
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August 2016
- FDA MedWatch: Eyesaline Eyewash by Honeywell - Recall
- FDA MedWatch: Oxacillin for Injection, USP, 10g by Sagent - Recall
- Newly Released Treatment of Drug-Susceptible Tuberculosis (TB) Guidelines
- AKF Press Release: Disaster Relief Program Activated to Help Kidney Patients Affected by Floods in LA and MS
- FDA:MedWatch - July 2016 Safety Labeling Changes
- FDA Company Announcement: PharmaTech LLC Issues Voluntary Nationwide Recall
- Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter
- CDC Guidance for Travel and Testing of Pregnant Women for Zika
- 2016 DOHMH Advisory #26: Tick-borne Disease Advisory
- FDA: Saety Alert - Comfort Shield Barrier Cream Cloths by Sage Products -Recall
- June 2016
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July 2016
- Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication – Warnings Updated Due to Disabling Side Effects
- Zika Update: New FDA Recommendations
- Oral Liquid Docusate Sodium by PharmaTech: Recall – Contaminated with B. Cepacia
- INRatio and INRatio2 PT/INR Monitor System by Alere: Recall – Potentially Inaccurate INR Results
- Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication – Serious Bleeding Risk
- UNOS/OPTN Zika Bulletin
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2018
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December 2018
- Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips
- Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients
- Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP
- Mylan Expands Its Voluntary Nationwide Recall
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November 2018
- Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall
- Outbreak Alert Update: Potential Life-Threatening Vitamin K-Dependent Antagonist Coagulopathy Associated With Synthetic Cannabinoids Use
- Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9%
- Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide
- October 2018
- October 2018
- September 2018
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August 2018
- Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up
- SGLT2 Inhibitors for Diabetes: Rare Occurrences of a Serious Infection of the Genital Area
- Class 2 Device Recall AMIA Automated PD Cycler
- Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery
- FDA updates on valsartan recalls
- Hepatitis Updates
- Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant
- FDA updates on valsartan recalls
- AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial
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July 2018
- Update on Valsartan Recalls: FDA updates both lists of products included in the recall and the list of products NOT included in the recall
- UPDATE: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication
- FDA Updates on Valsartan Recalls
- Update to FDA Announcement Re Voluntary Recall of Several Medicines Containing Valsartan
- Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions
- FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity
- Rising Numbers of Deaths Involving Fentanyl and Fentanyl Analogs, Including Carfentanil, and Increased Usage and Mixing with Non-opioids
- Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects
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June 2018
- Outbreak of Hepatitis A Virus (HAV) Infections among Persons Who Use Drugs and Persons Experiencing Homelessness
- Class 2 Device Recall Liberty Select Cycler
- Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection
- Update – CDC Recommendations for Managing and Reporting Shigella Infections with Possible Reduced Susceptibility to Ciprofloxacin
- HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power Source and the Controller
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May 2018
- HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion
- Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter
- Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter
- Outbreak Alert Update: Potential Life-Threatening Vitamin K-Dependent Antagonist Coagulopathy Associated With Synthetic Cannabinoids Use
- Liberty Select Cycler Recall
- April 2018
- March 2018
- February 2018
- January 2018
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December 2018
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2019
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September 2019
- Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg
- Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product
- Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP
- Zantac (ranitidine): Safety Information
- Hospira, Inc., Issues A Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER
- Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension
- The Metrix Company of Dubuque, Iowa is Recalling Specific Lots of the Empty IV Flexible Containers
- August 2019
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July 2019
- COVIDIEN LLC Issues Voluntary Recall
- Becton Dickinson (BD) Recalls Alaris Infusion Sets for the Alaris Pump Model 8100
- Voluntary Recall: BAxter REVACLEAR 400 Dialyzer
- Voluntary Recall: Baxter REVACLEAR 300 Dialyzer
- Certain Medtronic MiniMed Insulin Pumps Have Potential Cybersecurity Risks: FDA Safety Communication
- June 2019
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May 2019
- FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the U.S.
- Novartis Issues Voluntary Nationwide Recall of Promacta® 12.5 mg for Oral Suspension Due to Potential Peanut Contamination
- FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers
- Par Pharmaceutical, Inc. Issues Voluntary Nationwide Recall of One Lot of Mycophenolate Mofetil for Injection, USP
- Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance
- Legacy Pharmaceutical Packaging Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg
- Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP
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April 2019
- Medical Components, Inc. (dba MedComp) is Voluntarily Recalling its 14F SLX Double Lumen Full Tray Hemodialysis Catheter Insertion Kits
- Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling
- Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall
- FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers
- The FDA Warns Against Use of Previously Owned Test Strips or Test Strips Not Authorized for Sale in the United States
- Influenza Season Continues with an Increase in Influenza A(H3N2) Activity
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February 2019
- Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error
- Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Risk of Device "Lockup" (Freezing)
- Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide
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March 2019
- Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter
- Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg
- American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity
- FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan
- FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan
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October 2019
- Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup
- Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets
- Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules
- Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S.
- Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market
- Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue
- URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices
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November 2019
- The FDA has announced a recall of 13 Fr. Trialysis Catheter with Alphacurve
- Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution
- Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine
- American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup
- Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine
- Medtronic Recalls MiniMed Insulin Pumps for Potential Cybersecurity Risks
- December 2019
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September 2019
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2020
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August 2020
- FDA Urges Consumers Not Use Certain Hand Sanitizer Products
- CME America Updates Recall of BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion
- LABORATORIOS JALOMA S.A. de C.V. Issues Voluntary Recall of the Jaloma Antiseptic Hand Sanitizer Due to the Potential Presence of Undeclared Methanol
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July 2020
- Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol
- FDA Update on Hand Sanitizers with Methanol
- 4e Brands North America Issues Nationwide Voluntary Recall of Hand Sanitizer Due to Potential Presence of Undeclared Methanol
- Recall: Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate
- False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care Providers
- FDA Updates on Hand Sanitizers with Methanol
- Recall: Granules Pharmaceuticals
- Recall: FDA Advises Not to Use Eskbiochem Hand Sanitizer
- Serious Adverse Health Effects Associated with Methanol-based Hand Sanitizers
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June 2020
- Certain COVID-19 Serology/Antibody Tests Should Not Be Used
- Important Information on the Use of Serological (Antibody) Tests for COVID-19
- Recall: Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, Product Code 114435, UDI 37332414112401, 3 lots
- Recall: Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, Product Code 114434, UDI 47332414112395, 5 lots
- Recall: Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, Product Code 109536, UDI 37332414085217, 4 lots
- Recall: Gambro Cartridge Blood Set Prime Line, Product Code 101025, UDI 37332414007837, 56 lots
- Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment
- Lupin Pharmaceuticals Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride
- Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets
- Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets
- Use Compatible Transport Media with SARS-CoV-2 Tests that Use Bleach
- Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg
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May 2020
- Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems
- Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency
- Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with Coronavirus Disease 2019 (COVID-19)
- ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP Due to the Presence of Particulate Matter
- Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use
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April 2020
- Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication - FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems
- Trividia Health, Inc. Issues Nationwide Voluntary Recall for an Isolated TRUE METRIX AIR Blood Glucose Meter with Serial Number TA1548753
- COVID-19 Updates from FDA
- B. Braun Medical Inc. Issues Voluntary Nationwide Recall of One (1) Lot of Ceftazidime for Injection USP and Dextrose Injection USP (50 mL)
- Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers
- International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Clopidogrel Tablets USP
- Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP
- Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution
- FDA: Coronavirus Disease 2019 (COVID-19) Update
- Ivermectin Intended for Animals: Letter to Stakeholders - Do Not Use in Humans as a Treatment for COVID-19
- Latest COVID-19 Information From the FDA
- All Ranitidine Products (Zantac): Press Release - FDA Requests Removal
- CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion
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March 2020
- Severe Illness Associated with Using Non-Pharmaceutical Chloroquine Phosphate to Prevent and Treat Coronavirus Disease 2019 (COVID-19)
- Fecal Microbiota for Transplantation: Safety Alert - Regarding Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19
- FDA Alerts Patients and Health Care Professionals of EpiPen Auto-Injector Errors Related to Device Malfunctions and User Administration
- Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
- CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion
- Class II recall of ten lots of the Revaclear Capillary Dialyzer 300
- CDC COVID-19 Fact Sheets
- ASN - COVID-19 Awareness Poster
- Information for Screening and Management of COVID-19 in the Outpatient Dialysis Facility
- Interim Additional Guidance for Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed COVID-19 in Outpatient Hemodialysis Facilities
- Updated Guidance on Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19)
- Update and Interim Guidance on Outbreak of Coronavirus Disease 2019 (COVID-19)
- February 2020
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January 2020
- Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers
- Update and Interim Guidance on Outbreak of 2019 Novel Coronavirus (2019-nCoV) in Wuhan, China
- Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK® 15 Monitor/Defibrillator
- Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles
- Elevated Influenza Activity: Influenza B/Victoria and A(H1N1)pdm09 Viruses are the Predominant Viruses
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August 2020
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2017
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