BEUDAMED
    FDA Enforcement Class II Terminated

    Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories Electrolyte Tablets under the Brand of Medique and Medi-Lyte, Product Code: M963.

    Recall: Z-1090-2022 · Reported May 25, 2022

    Enforcement

    Recall Number
    Z-1090-2022
    Event ID
    89899
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Total Resources Intl
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 25, 2022
    Initiation Date
    March 11, 2022
    Classification Date
    May 13, 2022
    Termination Date
    January 30, 2025
    Address
    420 S Lemon Ave Ste A, N/A, City of Industry, CA, 91789-2956, United States

    Description

    Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories Electrolyte Tablets under the Brand of Medique and Medi-Lyte, Product Code: M963.

    Reason

    ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into Total Resources Intl kits. Acetaminophen and electrolyte tablets were recalled due to a Fluid Bed Drier exhaust system breach, which presents the possibility of cross-contamination where the potential contaminations are well known API's at well below efficacious dose levels.

    Code Info

    Kit Item No./Lot/Expiration/Best if Used by Date: 01REF2621/19268-10 01REF2621/20085-10/3/31/22, 01REF2621/20274-05/8/31/22, 10OUT02086REV3/21026-04/8/31/22,

    Distribution

    US: IL, PA, VA, AR, TX, IA, DE, GA, NY, LA, AL, IN, MI, MO, NC, KS, CO, AZ, OH, MS, CA, FL, WI, KY, UT, OR, NH, TN, NV, CT

    Quantity

    891