BEUDAMED
    FDA Recall Terminated

    Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and cabinets First Aid Only, Inc., Vancouver, WA. Ibuprofen Tablets, Item A405-WIP, Item A405-10 Ibuprofen Tablets, Item FAE-7014;; Ibuprofen Tablets, Item H430; Ibuprofen Tablets, Item I431; Ibuprofen Tablets, item J432 and Ibuprofen Tablets, item Z6100

    Recall: Z-0855-2008 · Initiated December 10, 2007

    Recall

    Recall Number
    Z-0855-2008
    Event Number
    46198
    Firm
    First Aid Only Inc
    FEI Number
    3023917
    Product Code
    GAA41
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 10, 2007
    Posted
    February 19, 2008
    Terminated
    April 8, 2011
    Address
    11101 Ne 37th Cir, Vancouver, WA, 98682-7218

    Description

    Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and cabinets First Aid Only, Inc., Vancouver, WA. Ibuprofen Tablets, Item A405-WIP, Item A405-10 Ibuprofen Tablets, Item FAE-7014;; Ibuprofen Tablets, Item H430; Ibuprofen Tablets, Item I431; Ibuprofen Tablets, item J432 and Ibuprofen Tablets, item Z6100

    Reason

    Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet refills, and cabinets, is being recalled for failing its USP limits for impurities during stability testing.

    Action

    The firm issued an Urgent Device Recall letter dated 10/10/07 to consignees receiving any of the products. The letter instructs consignees to return any recalled product to the firm. If any recalled prdoucts were further distributed, the consignee was requested to notify those consignees and have product returned.

    Distribution

    Worldwide: USA and to one distributor in Dubai, United Arab Emirates.

    Quantity

    62,302 tablets