BEUDAMED
    FDA Recall Terminated

    REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a cartridge, 5 cartridges to a kit, catalog Number 33999. The label shows the product is ''Mfg for'' REMEL, Lenexa,KS.

    Recall: Z-0613-03 · Initiated December 5, 2002

    Recall

    Recall Number
    Z-0613-03
    Event Number
    25250
    Firm
    Remel, Inc.
    FEI Number
    1924669
    Product Code
    JTN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 5, 2002
    Posted
    March 6, 2003
    Terminated
    March 31, 2003
    Address
    12076 Santa Fe Dr, Lenexa, KS, 66215

    Description

    REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a cartridge, 5 cartridges to a kit, catalog Number 33999. The label shows the product is ''Mfg for'' REMEL, Lenexa,KS.

    Reason

    Packages of Cefuroxime susceptibility disks erroneously contained Cefaclor susceptibility disks.

    Action

    Recall letters dated 12/5/02 were issued requesting destruction of the product by the customer.

    Distribution

    The product was distributed nationwide to 62 medical facilities including 3 military and 4 government accounts. No foreign accounts were reported.

    Quantity

    104 Pkg