1. 2019 Biologics Recalls

    2019 Biologics Recalls






    Date Notification
    Brand Name
    Product Description
  2. Important Drug Information - Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)]

    CSL Behring LLC is alerting customers to a misalignment in the printing of the data on the folding box of Humate-P that might lead to confusion of the user.
  3. Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables Due to a Lack of Sterility Assurance

    Viatrexx Bio Incorporated, Newark, Delaware is voluntarily recalling 10 mL sterile injectable vials of products, listed in the table below with lot numbers, to the consumer level. The products were sold exclusively to practitioners for office use. The products were manufactured in a manner that cann
  4. Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance

    Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products, within expiry, to the consumer level. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA.
  5. 2019 Medical Device Recalls

    The list below contains recalls that were issued in 2019.
  6. ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of Plum and Sapphire Microbore Infusion Sets with Inline Filters

    ICU Medical, Inc. announced a voluntary recall on 29 July 2019 of certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters due to the potential for small amounts of fluid leaking out of the air vents on the inline filters. To date, ICU Medical is not aware of adverse events rela
  7. Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue

    Medtronic is recalling the 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the device resulting in detached fragments that could result in the underlying stainless-steel braid wires being exposed.
  8. Lung Injury Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street

    FDA is strengthening its warning to consumers to stop using vaping products containing THC amid more than 1,000 reports of lung injuries—including some resulting in deaths—following the use of vaping products.
  9. CBER FY 2019 Recall Postings

    Listing of CBER FY 2019 Recall Postings
  10. CBER FY 2018 Recall Postings

    List of CBER FY 2018 Recall Postings.
  11. Bristol

    Monday-Friday: 9am - 6pm
    Saturday: Closed
    Sunday: Closed
    Phone: 802.453.2999
    Fax: 802.453.4006

    Middlebury

    Monday-Friday: 9am - 6pm
    Saturday: 9am - 3pm
    Sunday: 10am - 2pm
    Phone: 802.388.3784
    Fax: 802.388.1720

    Vergennes

    Monday-Friday: 9am - 6pm
    Saturday: 9am - 1pm
    Sunday: Closed
    Phone: 802.877.1190
    Fax: 802.877.1197