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June 2020

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  • Certain COVID-19 Serology/Antibody Tests Should Not Be Used

    Thursday, June 25, 2020
    The U.S. Food and Drug Administration (FDA) recommends that clinical laboratories and health care providers stop using COVID-19 antibody tests that are listed on FDA’s “removed” test list, found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage. The “removed”...

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  • Important Information on the Use of Serological (Antibody) Tests for COVID-19

    Thursday, June 25, 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...

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  • Recall: Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, Product Code 114435, UDI 37332414112401, 3 lots

    Tuesday, June 23, 2020
    Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems. Potential disconnection of tubing set.

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  • Recall: Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, Product Code 114434, UDI 47332414112395, 5 lots

    Tuesday, June 23, 2020
    Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems. Potential disconnection of tubing set.

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  • Recall: Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, Product Code 109536, UDI 37332414085217, 4 lots

    Tuesday, June 23, 2020
    Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems. Potential disconnection of tubing set.

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  • Recall: Gambro Cartridge Blood Set Prime Line, Product Code 101025, UDI 37332414007837, 56 lots

    Tuesday, June 23, 2020
    Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems. Potential disconnection of tubing set.

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  • Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment

    Tuesday, June 16, 2020
    FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir.

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  • Lupin Pharmaceuticals Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride

    Monday, June 15, 2020
    Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity...

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  • Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets

    Monday, June 8, 2020
    Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the...

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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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