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  • Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets

    Monday, June 8, 2020
    Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of...

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  • Use Compatible Transport Media with SARS-CoV-2 Tests that Use Bleach

    Monday, June 8, 2020
    The U.S. Food and Drug Administration (FDA) reminds laboratory staff to use transport media (the liquid that maintains a specimen sample while it is transported to a laboratory) that are compatible with the SARS-CoV-2 testing platforms and the processes used in their laboratory to process samples...

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  • Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg

    Wednesday, June 3, 2020
    Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level.

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  • Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems

    Friday, May 29, 2020
    The U.S. Food and Drug Administration (FDA) reminds reprocessing staff in health care facilities to use the correct decontamination cycle associated with certain models of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems and to only decontaminate compatible N95 or...

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  • Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency

    Tuesday, May 26, 2020
    Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the...

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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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