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  • Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with Coronavirus Disease 2019 (COVID-19)

    Friday, May 15, 2020

    The Centers for Disease Control and Prevention (CDC) is providing 1) background information on several cases of a recently reported multisystem inflammatory syndrome in children (MIS-C) associated with coronavirus disease 2019 (COVID-19); and 2) a case definition for this syndrome. CDC recommends healthcare providers report any patient who meets the case definition to local, state, and territorial health departments to enhance knowledge of risk factors, pathogenesis, clinical course, and treatment of this syndrome.

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  • ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP Due to the Presence of Particulate Matter

    Tuesday, May 12, 2020
    ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer's Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware of this issue through a single customer complaint.

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  • Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use

    Monday, May 4, 2020
    Vascular Solutions, Inc. is recalling the Langston Dual Lumen Catheter because there is a potential the inner catheter may separate during use. If the inner catheter separates, it could cause serious health conditions including additional surgical procedures to remove the separated section, damage...

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  • 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

    Friday, April 24, 2020

    FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease.  We authorized their temporary use only in hospitalized patients with COVID-19 when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (EUA).  These medicines have a number of side effects, including serious heart rhythm problems that can be life-threatening.

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  • Trividia Health, Inc. Issues Nationwide Voluntary Recall for an Isolated TRUE METRIX AIR Blood Glucose Meter with Serial Number TA1548753

    Wednesday, April 22, 2020
    Trividia Health, Inc. today announced it is initiating a nationwide voluntary recall of one (1) TRUE METRIX® AIR Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into storebrand or retail branded packaging.

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  • COVID-19 Updates from FDA

    Wednesday, April 22, 2020
    Along with other federal, state, and local agencies and public health officials across the country, the FDA continues critical work to protect public health during the COVID-19 pandemic.

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  • B. Braun Medical Inc. Issues Voluntary Nationwide Recall of One (1) Lot of Ceftazidime for Injection USP and Dextrose Injection USP (50 mL)

    Tuesday, April 21, 2020
    Braun Medical Inc. (B. Braun) is voluntarily recalling one (1) lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container to the hospital/user level.. During stability testing of Batch H8J812, test results were found to exceed the specification...

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  • Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers

    Tuesday, April 21, 2020

    The U.S. Food and Drug Administration (FDA) recommends that health care providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. Health care providers should also be aware of the limitations of these tests and the risks to patients and the community if the test results are used as the sole basis to diagnose COVID-19.

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  • International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Clopidogrel Tablets USP

    Friday, April 17, 2020
    International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel tablets USP 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP...

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  • Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP

    Friday, April 17, 2020
    Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level.

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