BEUDAMED
    FDA Recall 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 · Initiated March 11, 2022

    Recall

    Recall Number
    Z-1090-2022
    Event Number
    89899
    Firm
    Total Resources Intl
    FEI Number
    3002703161
    Product Code
    LRR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 11, 2022
    Terminated
    January 30, 2025
    Address
    420 S Lemon Ave, Ste A, City of Industry, CA, 91789-2956

    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.

    Action

    On 03/11/22 recall notices were sent to customers who were asked to do the following: 1) Examine your inventory and quarantine product subject to recall, which is the ULTRAtab products inside the kits, not the kits themselves . 2) The recall is extending to the retail level. If affected product has been further distributed, identify your customers, and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification. 3) Complete and return the Recall Acknowledgement to the recalling firm acknowledging receipt and understanding of the recall notice and documenting affected product (inside the kits) disposition. Affected products that are on hand are either marked as destroyed or returned. Customers with additional questions are encouraged to contact the recalling firm at (855) 883-3080 or email [email protected] Monday through Friday between 8:30 am to 3:30 pm (PST).

    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