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Alerts and Recalls

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  • Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Due to Risk of Shortened Battery Life

    Monday, April 12, 2021
    Medtronic is recalling the specified ICDs and CRT-Ds due to an unexpected and rapid decrease in battery life. The decrease in battery life is caused by a short circuit and will cause some devices to produce a “Recommended Replacement Time” (first warning that the battery is low) earlier...

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  • FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities

    Friday, April 9, 2021
    The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse. Based on the increased domestic supply of new respirators...

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  • Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System

    Wednesday, April 7, 2021
    The U.S. Food and Drug Administration today announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples. Samples collected at home are then sent...

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  • A-S Medication Solutions Issues Voluntary Nationwide Recall of Acetaminophen Extra Strength Tablets Contained in Health Essentials Kits Due to Mislabeling

    Monday, April 5, 2021
    Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. See the photo below. This recall is being...

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  • Acute Non-Viral Hepatitis of Unknown Etiology Potentially Associated with an Alkaline Water Product

    Wednesday, March 31, 2021
    Five cases of acute non-viral hepatitis of unknown etiology in children were reported to the Southern Nevada Health District (SNHD) between November and December 2020. The Centers for Disease Control and Prevention (CDC) is assisting the SNHD in investigating a potential link between these...

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  • Lamictal (lamotrigine): Drug Safety Communication - Studies Show Increased Risk of Heart Rhythm Problems in Patients with Heart Disease

    Wednesday, March 31, 2021
    An FDA review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine Lamictal (lamotrigine). FDA wants to evaluate whether other medicines in the same drug class have...

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  • SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests

    Wednesday, March 31, 2021
    The SARS-CoV-2 virus has mutated over time, resulting in genetic variation in the population of circulating viral strains over the course of the COVID-19 pandemic. Molecular, antigen, and serology tests are affected by viral mutations differently due to the inherent design differences of each test.

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  • Zydus Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection, 50 mg/mL Due to Crystallization

    Monday, March 29, 2021
    Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials.

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  • BD Expands Voluntary Recall of ChloraPrep™ 3 mL Applicator Nationwide to Include All U.S. States

    Monday, March 29, 2021
    BD (Becton, Dickinson and Company), a leading global medical technology company, has revised its press release dated March 19, 2021 relating to an expanded voluntary recall that was initiated on June 23, 2020 for specified catalog numbers of the ChloraPrep™ 3 mL applicator due to possible...

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  • Personal Protective Equipment EUAs

    Thursday, March 25, 2021
    Personal Protective Equipment refers to protective clothing, helmets, gloves, face shields, goggles, respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness. To help address concerns about availability during the COVID-19 pandemic, the FDA has...

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