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2020

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  • CME America Updates Recall of BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion

    Thursday, August 6, 2020
    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

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  • LABORATORIOS JALOMA S.A. de C.V. Issues Voluntary Recall of the Jaloma Antiseptic Hand Sanitizer Due to the Potential Presence of Undeclared Methanol

    Monday, August 3, 2020
    LABORATORIOS JALOMA S.A. de C.V. is voluntarily recalling all lots and all bottle sizes of the Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% With vitamin E to the consumer level. This recall has been initiated because FDA sampled the 500 mL product and found it to be contaminated with...

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  • Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

    Thursday, July 30, 2020
    The U.S. Food and Drug Administration continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and antifreeze that can be toxic when absorbed...

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  • FDA Update on Hand Sanitizers with Methanol

    Wednesday, July 29, 2020
    FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be...

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  • 4e Brands North America Issues Nationwide Voluntary Recall of Hand Sanitizer Due to Potential Presence of Undeclared Methanol

    Wednesday, July 15, 2020
    San Antonio, Texas, 4e Brands North America is voluntarily recalling ten (10) bottle sizes of Hand Sanitizers to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

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  • Recall: Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate

    Wednesday, July 8, 2020
    Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured by...

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  • False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care Providers

    Wednesday, July 8, 2020
    The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found approximately three percent (3%) of results were...

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  • FDA Updates on Hand Sanitizers with Methanol

    Wednesday, July 8, 2020
    7-2-2020] FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance...

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  • Recall: Granules Pharmaceuticals

    Tuesday, July 7, 2020
    Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable...

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  • Recall: FDA Advises Not to Use Eskbiochem Hand Sanitizer

    Monday, July 6, 2020
    Update [6/29/2020] FDA is alerting consumers of Saniderm Products and UVT Inc.’s voluntary recall of Saniderm Advanced Hand Sanitizer. Following FDA’s recommendation, two distributors – Saniderm Products and UVT – agreed to recall Saniderm Advanced Hand Sanitizer packaged in...

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