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  • Serious Adverse Health Effects Associated with Methanol-based Hand Sanitizers

    Monday, July 6, 2020
    Most commercially available alcohol-based hand sanitizers or rubs (ABHSR) contain either ethanol or isopropanol as active ingredients. On June 19, 2020, the U.S. Food and Drug Administration (FDA) advised consumers not to use any hand sanitizer manufactured by “Eskbiochem SA de CV” in...

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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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