Skip to main content
 

2020

Top
  • 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...

    Read More
  • 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...

    Read More
  • 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...

    Read More
  • 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...

    Read More
  • 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...

    Read More
  • 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...

    Read More
  • 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”...

    Read More
  • 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...

    Read More
  • 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.

    Read More
  • 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.

    Read More