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  • Alembic Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Telmisartan Tablets, USP, 20 mg Due to Label Mix-Up

    Thursday, March 25, 2021
    Bridgewater, NJ, Alembic Pharmaceuticals, Inc is voluntarily recalling one lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one bottle labelled as...

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  • FDA Advises Health Care Professionals not to Use ChloraPrep 3 mL Applicators Manufactured by BD (Becton, Dickinson and Company)

    Monday, March 22, 2021
    FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company), due to microbial contamination risks. The drug was distributed globally and is labeled with “CareFusion, El Paso, TX.”

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  • FDA Authorizes Revisions to Fact Sheets to Address SARS-CoV-2 Variants for Monoclonal Antibody Products under Emergency Use Authorization

    Friday, March 19, 2021
    Today, the U.S. Food and Drug Administration authorized revised fact sheets for health care providers to include additional information on susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody (mAb) therapies that are available through an Emergency Use Authorization (EUA) for the...

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  • Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System-Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff, and Health Care Providers

    Monday, March 15, 2021
    The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff, point-of-care (POC) facility staff, and health care providers that false positive results can occur with the Roche Molecular Systems, Inc. (Roche) cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the...

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  • Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL Due to Potential Lack of Sterility Assurance

    Monday, March 15, 2021
    Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL). This product was manufactured by Indoco Remedies Ltd. and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of...

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  • Combat Medical Systems, LLC, Recalls Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set, Fresh Whole Blood Transfusion Set, Fresh Whole Blood Donor Set for Possible Broken or Bent Needles

    Monday, March 15, 2021
    Combat Medical is recalling the convenience kits because the needle in the blood pack may bend or disconnect from the blood bag. The possible needle damage only occurs during the packaging process before being received by the user. However, a user will not be able to identify if the needle is...

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  • Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with the Incorrect Strength

    Wednesday, March 10, 2021
    Bryant Ranch Prepack is voluntarily recalling 4 lots of Spironolactone tablets to the consumer level. The products have been found to be mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles...

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  • Why You Should Not Use Ivermectin to Treat or Prevent COVID-19

    Monday, March 8, 2021
    COVID-19. We’ve been living with it for what sometimes seems like forever. Given the number of deaths that have occurred from the disease, it’s perhaps not surprising that some consumers are looking at unconventional treatments, not approved or authorized by the Food and Drug...

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  • Improper Use of Thermal Imaging Devices: FDA Safety Communication

    Monday, March 8, 2021
    The U.S. Food and Drug Administration (FDA) is alerting consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature that improper use of these systems may provide inaccurate temperature readings. These devices are also known as...

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  • Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped

    Wednesday, March 3, 2021
    Medtronic is recalling the HVAD Pump Implant Kit because the device may fail to initially start, restart, or have a delay in restarting after the pump was stopped. These delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of...

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